<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/NCT01664923</url>
  </required_header>
  <id_info>
    <org_study_id>MDV3100-09</org_study_id>
    <secondary_id>C3431014</secondary_id>
    <nct_id>NCT01664923</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer</brief_title>
  <acronym>STRIVE</acronym>
  <official_title>STRIVE: A MULTICENTER PHASE 2, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF ENZALUTAMIDE VS. BICALUTAMIDE IN MEN WITH PROSTATE CANCER WHO HAVE FAILED PRIMARY ANDROGEN DEPRIVATION THERAPY</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Astellas Pharma Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medivation LLC, a wholly owned subsidiary of Pfizer Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Pfizer</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the safety and efficacy of enzalutamide vs&#xD;
      bicalutamide in asymptomatic or mildly symptomatic patients with prostate cancer who have&#xD;
      disease progression despite primary androgen deprivation therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a multicenter phase 2, randomized, double-blind, efficacy and safety study of&#xD;
      enzalutamide (160 mg/day) vs. bicalutamide (50 mg/day) in patients with recurrent prostate&#xD;
      cancer who have serologic and/or radiographic disease progression despite primary androgen&#xD;
      deprivation therapy.&#xD;
&#xD;
      Throughout the study, safety and tolerability will be assessed by the recording of adverse&#xD;
      events, monitoring of vital signs, physical examinations, and safety laboratory evaluations.&#xD;
&#xD;
      Following study unblinding, study patients receiving enzalutamide or bicalutamide at the time&#xD;
      of unblinding and qualifying patients randomized to bicalutamide who discontinued prior to&#xD;
      unblinding will be offered the opportunity to receive open label enzalutamide treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2012</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.</time_frame>
    <description>PFS was defined as time from randomization to earliest objective evidence of prostate specific-antigen (PSA) progression, radiographic progression, or death on study. PSA progression was defined as ≥ 25% increase in PSA with an absolute increase ≥ 2 ng/mL above the nadir and was to be confirmed by a second consecutive assessment. Radiographic progression in bone was based on The Prostate Cancer Clinical Trials Working Group (PCWG2) guidelines defined as at least 2 new lesions on bone scan. Radiographic progression in soft tissue on Computerized Tomography/Magnetic Resonance Imaging (CT/MRI) was based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). CT/MRI and bone scans were read locally by the same radiologist (or nuclear medicine physician for interpretation of bone scans) whenever possible. Participants not known to have had a PFS event at the time of the analysis data cutoff were censored at the date of last assessment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to PSA Progression</measure>
    <time_frame>From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.</time_frame>
    <description>PSA progression was defined as ≥ 25% increase in PSA with an absolute increase ≥ 2 ng/mL above the nadir and was to be confirmed by a second consecutive assessment at least 3 weeks later. Participants not known to have had PSA progression were censored at the date of last PSA assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a PSA Response ≥ 50%</measure>
    <time_frame>From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.</time_frame>
    <description>PSA response was defined as a reduction in PSA of at least 50% from baseline at any post baseline assessment confirmed by a second PSA assessment at least 3 weeks later.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Radiographic PFS</measure>
    <time_frame>From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.</time_frame>
    <description>Duration of radiographic PFS was defined as the time from randomization to the earliest objective evidence of radiographic disease progression or death on study and was to be evaluated for participants with metastatic disease at study entry. Radiographic disease progression in bone was based on PCWG2 guidelines defined as at least 2 new lesions on bone scan. Radiographic disease progression in soft tissue on CT/MRI was based on RECIST 1.1. CT/MRI and bone scans were read locally by the same radiologist (or nuclear medicine physician for interpretation of bone scans) whenever possible. Participants not known to have had radiographic progression at the time of analysis data cutoff were censored at the date of last radiographic assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life: Time to Degradation of Functional Assessment of Cancer Therapy - Prostate (FACT-P)</measure>
    <time_frame>From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.</time_frame>
    <description>The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess patient function in 4 domains: physical, social/family, emotional, and functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score (0 to 156) with higher scores representing better quality of life. Time to degradation of FACT-P was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the global FACT-P score for each participant. Participants with no score degradation at the time of analysis data cutoff were censored at the date of last assessment showing no degradation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best Overall Soft Tissue Response</measure>
    <time_frame>From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.</time_frame>
    <description>Best overall soft tissue response is defined as partial response (PR) or complete response (CR) while on study treatment based on investigator assessment of target, nontarget, and new lesions using RECIST 1.1. Only participants in the metastatic population with measurable soft tissue disease (at least 1 target lesion identified per RECIST 1.1) at screening were included in the analysis. All percentages are based on number of participants with metastatic and measurable soft tissue disease at screening in each treatment group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>From first dose of study drug until the end of open label phase (up to maximum duration of 65 months)</time_frame>
    <description>An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. A treatment emergent AE defined as an event that emerged during treatment period (From first dose of study drug until end of open label phase [up to maximum duration of 65 months]) that was absent before treatment, or worsened during treatment period relative to pre-treatment state. AE included both serious and non- SAE. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An AE was considered related to study drug if event was assessed by investigator as probably or possibly related.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">396</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Enzalutamide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enzalutamide 160 mg/day orally</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bicalutamide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>50 mg/day orally</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Enzalutamide</intervention_name>
    <description>160 mg, daily, by mouth.</description>
    <arm_group_label>Enzalutamide</arm_group_label>
    <other_name>MDV3100</other_name>
    <other_name>Xtandi</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bicalutamide</intervention_name>
    <description>50 mg, daily, by mouth</description>
    <arm_group_label>Bicalutamide</arm_group_label>
    <other_name>Casodex</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males age 18 or older;&#xD;
&#xD;
          -  Histologically or cytologically confirmed adenocarcinoma of the prostate;&#xD;
&#xD;
          -  Ongoing androgen deprivation therapy;&#xD;
&#xD;
          -  Serum testosterone level ≤ 50 ng/dL (1.73 nmol/L) at the Screening visit;&#xD;
&#xD;
          -  Progressive disease at study entry defined by prostate-specific antigen (PSA)&#xD;
             progression and/or radiographic progression that occurred while the patient was on&#xD;
             primary androgen deprivation therapy;&#xD;
&#xD;
          -  Asymptomatic or mildly symptomatic from prostate cancer;&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;&#xD;
&#xD;
          -  Estimated life expectancy of ≥ 12 months;&#xD;
&#xD;
          -  Able to swallow the study drug and comply with study requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe concurrent disease, infection, or co-morbidity;&#xD;
&#xD;
          -  Known or suspected brain metastasis or active leptomeningeal disease;&#xD;
&#xD;
          -  History of another invasive malignancy within the previous 5 years other than treated&#xD;
             non-melanomatous skin cancer and American Joint Committee on Cancer (AJCC) Stage 0 or&#xD;
             Stage 1 cancers that have a remote probability of recurrence;&#xD;
&#xD;
          -  Absolute neutrophil count &lt; 1,500/µL, or platelet count &lt; 100,000/µL, or hemoglobin &lt;&#xD;
             9 g/dL at the Screening visit;&#xD;
&#xD;
          -  Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) &gt;&#xD;
             2.5 times the upper limit of normal (ULN) at the Screening visit;&#xD;
&#xD;
          -  Creatinine &gt; 2 mg/dL at the Screening visit;&#xD;
&#xD;
          -  Albumin &lt; 3.0 g/dL at the Screening visit;&#xD;
&#xD;
          -  History of seizure or any condition that may predispose to seizure;&#xD;
&#xD;
          -  Clinically significant cardiovascular disease;&#xD;
&#xD;
          -  Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer&#xD;
             disease within last 3 months);&#xD;
&#xD;
          -  Major surgery within 4 weeks of enrollment;&#xD;
&#xD;
          -  Use of opiate analgesics for pain from prostate cancer within 4 weeks of enrollment;&#xD;
&#xD;
          -  Radiation therapy for treatment of the primary tumor within 3 weeks of enrollment;&#xD;
&#xD;
          -  Prior radiation or radionuclide therapy for treatment of distant metastases;&#xD;
&#xD;
          -  Prior ketoconazole, abiraterone, or cytotoxic chemotherapy for prostate cancer;&#xD;
&#xD;
          -  Treatment with hormonal therapy or biologic therapy for prostate cancer within 4 weeks&#xD;
             of enrollment;&#xD;
&#xD;
          -  Use of antiandrogens within 4 weeks prior to enrollment;&#xD;
&#xD;
          -  Prior disease progression, as assessed by the Investigator, while receiving&#xD;
             bicalutamide;&#xD;
&#xD;
          -  Participation in a previous clinical trial of enzalutamide or an investigational agent&#xD;
             that inhibits the androgen receptor or androgen synthesis (patients who received&#xD;
             placebo are acceptable);&#xD;
&#xD;
          -  Use of an investigational agent within 4 weeks of enrollment;&#xD;
&#xD;
          -  Use of herbal products that may have hormonal anti-prostate cancer activity and/or are&#xD;
             known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids for&#xD;
             prostate cancer within 4 weeks of enrollment;&#xD;
&#xD;
          -  Any condition or reason that, in the opinion of the Investigator, interferes with the&#xD;
             ability of the patient to participate in the trial, which places the patient at undue&#xD;
             risk, or complicates the interpretation of safety data.&#xD;
&#xD;
        Open-Label Treatment Period:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Received randomized double blind treatment in MDV3100-09 as follows:&#xD;
&#xD;
               -  Randomized to enzalutamide and receiving enzalutamide at the time of study&#xD;
                  unblinding;&#xD;
&#xD;
               -  Randomized to bicalutamide and receiving bicalutamide at the time of study&#xD;
                  unblinding;&#xD;
&#xD;
               -  Randomized to bicalutamide and discontinued bicalutamide before study unblinding;&#xD;
&#xD;
          -  Willing to maintain androgen deprivation therapy with a gonadotropin releasing hormone&#xD;
             (GnRH) agonist/antagonist or has had a bilateral orchiectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Is currently or has taken commercially available enzalutamide (Xtandi) prior to&#xD;
             participation in this open-label extension;&#xD;
&#xD;
          -  Discontinued enzalutamide during the double-blind portion of the study prior to&#xD;
             unblinding;&#xD;
&#xD;
          -  Has any clinically significant cardiovascular, dermatologic, endocrine,&#xD;
             gastrointestinal, hematologic, hepatic, infectious, metabolic, neurologic,&#xD;
             psychiatric, psychologic, pulmonary, or renal disorder or any other condition,&#xD;
             including excessive alcohol or drug abuse, or secondary malignancy, that may interfere&#xD;
             with study participation in the opinion of the investigator or medical monitor;&#xD;
&#xD;
          -  Has a current or previously treated brain metastasis or leptomeningeal disease;&#xD;
&#xD;
          -  Has a history of seizure or any condition that may predispose to seizure (eg, prior&#xD;
             cortical stroke or significant brain trauma);&#xD;
&#xD;
          -  Has a history of loss of consciousness or transient ischemic attack within 12 months&#xD;
             of open label day 1;&#xD;
&#xD;
          -  Has taken cytotoxic chemotherapy or investigational therapy within 4 weeks before&#xD;
             enrollment (open label day 1).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Alabama at Birmingham，IDS Pharmacy</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Desert Springs Cancer Care</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85255</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Oncology Associates, PC - HOPE</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Oncology Associates, PC - HOPE</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urological Associates of Southern Arizona, PC</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85715</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urological Associates of Southern Arizona, PC</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Permanente Medical Group</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Center Lab Drawing Station</name>
      <address>
        <city>Antioch</city>
        <state>California</state>
        <zip>94509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Center Lab Drawing Station</name>
      <address>
        <city>Antioch</city>
        <state>California</state>
        <zip>94531</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Center Lab Drawing Station</name>
      <address>
        <city>Fairfield</city>
        <state>California</state>
        <zip>94533-6901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Center Lab Drawing Station</name>
      <address>
        <city>Gilroy</city>
        <state>California</state>
        <zip>95020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Permanente Medical Group</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tower Urology</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Clark Urology Clinic</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Department of Pharmaceutical Services</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Center Lab Drawing Station</name>
      <address>
        <city>Martinez</city>
        <state>California</state>
        <zip>94553</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Center Lab Drawing Station</name>
      <address>
        <city>Milpitas</city>
        <state>California</state>
        <zip>95035-5491</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Center Lab Drawing Station</name>
      <address>
        <city>Modesto</city>
        <state>California</state>
        <zip>95356</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Center Lab Drawing Station</name>
      <address>
        <city>Moutain View</city>
        <state>California</state>
        <zip>94041</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Center Lab Drawing Station</name>
      <address>
        <city>Napa</city>
        <state>California</state>
        <zip>94558-3313</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Center</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Center Lab Drawing Station</name>
      <address>
        <city>Pleasanton</city>
        <state>California</state>
        <zip>94558</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Center Lab Drawing Station</name>
      <address>
        <city>Redwood City</city>
        <state>California</state>
        <zip>94063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Center</name>
      <address>
        <city>Roseville</city>
        <state>California</state>
        <zip>95661</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Davis Comprehensive Cancer Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Davis Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95825</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Bernardino Urological Associates Medical Group</name>
      <address>
        <city>San Bernardino</city>
        <state>California</state>
        <zip>92404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Permanente Medical Group</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Center</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Center</name>
      <address>
        <city>San Leandro</city>
        <state>California</state>
        <zip>94577</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Permanente Medical Group</name>
      <address>
        <city>San Marcos</city>
        <state>California</state>
        <zip>92078</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Center</name>
      <address>
        <city>Santa Clara</city>
        <state>California</state>
        <zip>95051</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skyline Urology</name>
      <address>
        <city>Sherman Oaks</city>
        <state>California</state>
        <zip>91411</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Center</name>
      <address>
        <city>South San Francisco</city>
        <state>California</state>
        <zip>94080</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Standford Health Care</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skyline Urology</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Center</name>
      <address>
        <city>Vallejo</city>
        <state>California</state>
        <zip>94589</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Center</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94596</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anschutz Cancer Center Pavilion Pharmacy</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anschutz Inpatient Pavilion</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Cancer Center, Anschutz Cancer Pavilion</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Urology Center of Colorado</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>George Washington University - Medical Faculty Associates</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Urology institute</name>
      <address>
        <city>Daytona Beach</city>
        <state>Florida</state>
        <zip>32114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Coast Institute for Research, LLC</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Coast Institute for Research, LLC</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specialists In Urology</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Urology, PSC</name>
      <address>
        <city>Jeffersonville</city>
        <state>Indiana</state>
        <zip>47130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metairie Oncologist, LLC</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Clinic Foundation</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Urology, LLC</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chesapeake Urology Research Associates</name>
      <address>
        <city>Towson</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan Institute of Urology</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Oncology Hematology, P.A.</name>
      <address>
        <city>Edina</city>
        <state>Minnesota</state>
        <zip>55435-2150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Oncology Hematology, P.A.</name>
      <address>
        <city>Woodbury</city>
        <state>Minnesota</state>
        <zip>55125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barnes-Jewish West County Hospital</name>
      <address>
        <city>Creve Coeur</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barnes-Jewish Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University Infusion Center Pharmacy</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University, School of Medicine, 7th Floor, Center for Advanced Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Siteman Cancer Center - South County</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63129</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GU Research network,LLC / Urology Cancer Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Theurer Cancer Center at Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AccuMed Research Associates</name>
      <address>
        <city>Garden City</city>
        <state>New York</state>
        <zip>11530</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Medical Group of the Hudson Valley PC</name>
      <address>
        <city>Poughkeepsie</city>
        <state>New York</state>
        <zip>12601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Associated Medical Professionals of NY, PLLC</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolinas Medical Center-Steelcreek</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28278</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Clinical Trials, LLC</name>
      <address>
        <city>Concord</city>
        <state>North Carolina</state>
        <zip>28025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Urology Partners, PLLC</name>
      <address>
        <city>Concord</city>
        <state>North Carolina</state>
        <zip>28025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Chemotherapy Services</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance Urology Specialists, PA</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rowan Regional Medical Center</name>
      <address>
        <city>Salisbury</city>
        <state>North Carolina</state>
        <zip>28144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Health Urology</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Health</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TriState Urologic Services PSC Inc., dba The Urology Group</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Taussig Cancer Institute</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peace Harbor Hospital</name>
      <address>
        <city>Florence</city>
        <state>Oregon</state>
        <zip>97439</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Salem Hospital</name>
      <address>
        <city>Salem</city>
        <state>Oregon</state>
        <zip>97301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Urology Institute</name>
      <address>
        <city>Springfield</city>
        <state>Oregon</state>
        <zip>97477</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sacred Heart Nuclear Medicine</name>
      <address>
        <city>Springfield</city>
        <state>Oregon</state>
        <zip>97477</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lancaster Urology</name>
      <address>
        <city>Lancaster</city>
        <state>Pennsylvania</state>
        <zip>17604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jefferson Medical Oncology</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jefferson Urology Associates</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Cancer Center Hillman Cancer Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Nittany Physician Group</name>
      <address>
        <city>State College</city>
        <state>Pennsylvania</state>
        <zip>16801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Nittany Health</name>
      <address>
        <city>State College</city>
        <state>Pennsylvania</state>
        <zip>16803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charleston Hematology Oncology Associates, PA</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Urologic Research Center</name>
      <address>
        <city>Myrtle Beach</city>
        <state>South Carolina</state>
        <zip>29572</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology Associates P.C.</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology Clinics of North Texas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - Baylor Charles A. Sammons Cancer Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology-Memorial City</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology San Antonio Research</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah/Huntsman Cancer Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah/Huntsman Cancer Institute</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Oncology Associates</name>
      <address>
        <city>Hampton</city>
        <state>Virginia</state>
        <zip>23666</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Oncology Associates</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology of Virginia, PLLC.</name>
      <address>
        <city>Virginia Beach</city>
        <state>Virginia</state>
        <zip>23462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Mason Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Cancer Care Alliance</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin Clinical Sciences Center</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <results_first_submitted>February 22, 2016</results_first_submitted>
  <results_first_submitted_qc>May 9, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 23, 2016</results_first_posted>
  <last_update_submitted>January 7, 2019</last_update_submitted>
  <last_update_submitted_qc>January 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prostate cancer</keyword>
  <keyword>enzalutamide</keyword>
  <keyword>MDV3100</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bicalutamide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
    <ipd_url>https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Enzalutamide</title>
          <description>Participants received enzalutamide 160 milligram (mg), self-administered as four 40-mg capsules, and 1 bicalutamide matching placebo capsule once per day, by mouth for up to 29 months in double blind (DB) phase. Participants who completed DB phase and consented to participate in open label phase, received enzalutamide 160 mg, self-administered as four 40-mg capsules once per day by mouth for up to 36 months in open label phase.</description>
        </group>
        <group group_id="P2">
          <title>Bicalutamide Then Enzalutamide</title>
          <description>Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide matching placebo capsules for up to 29 months in DB phase. Participants who completed DB phase and consented to participate in open label phase, received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth for up to 36 months in open label phase.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period1:Double Blind Phase-29 Months</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="198"/>
                <participants group_id="P2" count="198"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Study Treatment</title>
              <participants_list>
                <participants group_id="P1" count="197"/>
                <participants group_id="P2" count="198"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="93"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="105"/>
                <participants group_id="P2" count="160"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Disease Progression</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="132"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized, But 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>Period 2: Open-label Phase-36 Months</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="93"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="93"/>
                <participants group_id="P2" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>On Treatment</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Disease progression</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Enzalutamide</title>
          <description>Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule in DB phase.</description>
        </group>
        <group group_id="B2">
          <title>Bicalutamide</title>
          <description>Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules in DB phase.</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="198"/>
            <count group_id="B2" value="198"/>
            <count group_id="B3" value="396"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt; 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>65-74 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="158"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ 75 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                    <measurement group_id="B2" value="97"/>
                    <measurement group_id="B3" value="174"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="198"/>
                    <measurement group_id="B2" value="198"/>
                    <measurement group_id="B3" value="396"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="198"/>
                    <measurement group_id="B2" value="198"/>
                    <measurement group_id="B3" value="396"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Progression Free Survival (PFS)</title>
        <description>PFS was defined as time from randomization to earliest objective evidence of prostate specific-antigen (PSA) progression, radiographic progression, or death on study. PSA progression was defined as ≥ 25% increase in PSA with an absolute increase ≥ 2 ng/mL above the nadir and was to be confirmed by a second consecutive assessment. Radiographic progression in bone was based on The Prostate Cancer Clinical Trials Working Group (PCWG2) guidelines defined as at least 2 new lesions on bone scan. Radiographic progression in soft tissue on Computerized Tomography/Magnetic Resonance Imaging (CT/MRI) was based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). CT/MRI and bone scans were read locally by the same radiologist (or nuclear medicine physician for interpretation of bone scans) whenever possible. Participants not known to have had a PFS event at the time of the analysis data cutoff were censored at the date of last assessment.</description>
        <time_frame>From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.</time_frame>
        <population>Intent-to-treat population: all participants randomly assigned to study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Enzalutamide</title>
            <description>Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule in DB phase.</description>
          </group>
          <group group_id="O2">
            <title>Bicalutamide</title>
            <description>Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules in DB phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival (PFS)</title>
          <description>PFS was defined as time from randomization to earliest objective evidence of prostate specific-antigen (PSA) progression, radiographic progression, or death on study. PSA progression was defined as ≥ 25% increase in PSA with an absolute increase ≥ 2 ng/mL above the nadir and was to be confirmed by a second consecutive assessment. Radiographic progression in bone was based on The Prostate Cancer Clinical Trials Working Group (PCWG2) guidelines defined as at least 2 new lesions on bone scan. Radiographic progression in soft tissue on Computerized Tomography/Magnetic Resonance Imaging (CT/MRI) was based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). CT/MRI and bone scans were read locally by the same radiologist (or nuclear medicine physician for interpretation of bone scans) whenever possible. Participants not known to have had a PFS event at the time of the analysis data cutoff were censored at the date of last assessment.</description>
          <population>Intent-to-treat population: all participants randomly assigned to study treatment.</population>
          <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="198"/>
                <count group_id="O2" value="198"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.4" lower_limit="16.5" upper_limit="NA">The upper limit of the 95% confidence interval was not available because an insufficient number of participants had an event at the time of analysis.</measurement>
                    <measurement group_id="O2" value="5.7" lower_limit="5.6" upper_limit="8.1"/>
                  </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 or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P-value based on log-rank test stratified by disease stage at study entry as reported on the case report form (CRF).</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.240</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.181</ci_lower_limit>
            <ci_upper_limit>0.320</ci_upper_limit>
            <estimate_desc>Hazard ratio is based on a Cox regression model (with treatment as the only covariate) stratified by disease stage at study entry and is relative to bicalutamide with &lt; 1 favoring enzalutamide.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to PSA Progression</title>
        <description>PSA progression was defined as ≥ 25% increase in PSA with an absolute increase ≥ 2 ng/mL above the nadir and was to be confirmed by a second consecutive assessment at least 3 weeks later. Participants not known to have had PSA progression were censored at the date of last PSA assessment.</description>
        <time_frame>From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.</time_frame>
        <population>Intent-to-treat population: all participants randomly assigned to study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Enzalutamide</title>
            <description>Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule in DB phase.</description>
          </group>
          <group group_id="O2">
            <title>Bicalutamide</title>
            <description>Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules in DB phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to PSA Progression</title>
          <description>PSA progression was defined as ≥ 25% increase in PSA with an absolute increase ≥ 2 ng/mL above the nadir and was to be confirmed by a second consecutive assessment at least 3 weeks later. Participants not known to have had PSA progression were censored at the date of last PSA assessment.</description>
          <population>Intent-to-treat population: all participants randomly assigned to study treatment.</population>
          <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="198"/>
                <count group_id="O2" value="198"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="19.4" upper_limit="NA">The median time to PSA progression and its upper limit of the 95% confidence interval were not available because an insufficient number of participants had an event at the time of analysis.</measurement>
                    <measurement group_id="O2" value="8.3" lower_limit="5.7" upper_limit="8.5"/>
                  </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 or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P-value based on log-rank test stratified by disease stage at study entry as reported on the CRF.</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.190</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.137</ci_lower_limit>
            <ci_upper_limit>0.264</ci_upper_limit>
            <estimate_desc>Hazard ratio is based on a Cox regression model (with treatment as the only covariate) stratified by disease stage at study entry and is relative to bicalutamide with &lt; 1 favoring enzalutamide.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a PSA Response ≥ 50%</title>
        <description>PSA response was defined as a reduction in PSA of at least 50% from baseline at any post baseline assessment confirmed by a second PSA assessment at least 3 weeks later.</description>
        <time_frame>From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.</time_frame>
        <population>Evaluable intent-to-treat population: all participants randomly assigned to study treatment and had a baseline and at least 1 post baseline PSA measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Enzalutamide</title>
            <description>Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule in DB phase.</description>
          </group>
          <group group_id="O2">
            <title>Bicalutamide</title>
            <description>Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules in DB phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a PSA Response ≥ 50%</title>
          <description>PSA response was defined as a reduction in PSA of at least 50% from baseline at any post baseline assessment confirmed by a second PSA assessment at least 3 weeks later.</description>
          <population>Evaluable intent-to-treat population: all participants randomly assigned to study treatment and had a baseline and at least 1 post baseline PSA measurement.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="192"/>
                <count group_id="O2" value="195"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.3" lower_limit="75.0" upper_limit="86.5"/>
                    <measurement group_id="O2" value="31.3" lower_limit="24.8" upper_limit="38.3"/>
                  </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 or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Comparison of the 2 treatment groups using the Cochran-Mantel-Haenszel mean score test stratified by disease stage at study entry.</method_desc>
            <param_type>Difference in rates</param_type>
            <param_value>50.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>41.4</ci_lower_limit>
            <ci_upper_limit>58.5</ci_upper_limit>
            <estimate_desc>Enzalutamide response rate minus bicalutamide response rate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Radiographic PFS</title>
        <description>Duration of radiographic PFS was defined as the time from randomization to the earliest objective evidence of radiographic disease progression or death on study and was to be evaluated for participants with metastatic disease at study entry. Radiographic disease progression in bone was based on PCWG2 guidelines defined as at least 2 new lesions on bone scan. Radiographic disease progression in soft tissue on CT/MRI was based on RECIST 1.1. CT/MRI and bone scans were read locally by the same radiologist (or nuclear medicine physician for interpretation of bone scans) whenever possible. Participants not known to have had radiographic progression at the time of analysis data cutoff were censored at the date of last radiographic assessment.</description>
        <time_frame>From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.</time_frame>
        <population>All participants with metastatic disease at study entry and randomly assigned to study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Enzalutamide</title>
            <description>Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule in DB phase.</description>
          </group>
          <group group_id="O2">
            <title>Bicalutamide</title>
            <description>Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules in DB phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Radiographic PFS</title>
          <description>Duration of radiographic PFS was defined as the time from randomization to the earliest objective evidence of radiographic disease progression or death on study and was to be evaluated for participants with metastatic disease at study entry. Radiographic disease progression in bone was based on PCWG2 guidelines defined as at least 2 new lesions on bone scan. Radiographic disease progression in soft tissue on CT/MRI was based on RECIST 1.1. CT/MRI and bone scans were read locally by the same radiologist (or nuclear medicine physician for interpretation of bone scans) whenever possible. Participants not known to have had radiographic progression at the time of analysis data cutoff were censored at the date of last radiographic assessment.</description>
          <population>All participants with metastatic disease at study entry and randomly assigned to study treatment.</population>
          <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="128"/>
                <count group_id="O2" value="129"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="16.7" upper_limit="NA">The median duration of radiographic PFS and its upper limit of the 95% confidence interval were not available because an insufficient number of participants had an event at the time of analysis.</measurement>
                    <measurement group_id="O2" value="8.3" lower_limit="8.1" upper_limit="11.1"/>
                  </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 or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Log Rank</method>
            <method_desc>P-value is based on an unstratified log-rank test.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.324</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.211</ci_lower_limit>
            <ci_upper_limit>0.497</ci_upper_limit>
            <estimate_desc>Hazard ratio is based on an unstratified Cox-regression model (with treatment as the only covariate) and is relative to bicalutamide with &lt; 1 favoring enzalutamide.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life: Time to Degradation of Functional Assessment of Cancer Therapy - Prostate (FACT-P)</title>
        <description>The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess patient function in 4 domains: physical, social/family, emotional, and functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score (0 to 156) with higher scores representing better quality of life. Time to degradation of FACT-P was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the global FACT-P score for each participant. Participants with no score degradation at the time of analysis data cutoff were censored at the date of last assessment showing no degradation.</description>
        <time_frame>From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.</time_frame>
        <population>Intent-to-treat population: all participants randomly assigned to study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Enzalutamide</title>
            <description>Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule in DB phase.</description>
          </group>
          <group group_id="O2">
            <title>Bicalutamide</title>
            <description>Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules in DB phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life: Time to Degradation of Functional Assessment of Cancer Therapy - Prostate (FACT-P)</title>
          <description>The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess patient function in 4 domains: physical, social/family, emotional, and functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score (0 to 156) with higher scores representing better quality of life. Time to degradation of FACT-P was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the global FACT-P score for each participant. Participants with no score degradation at the time of analysis data cutoff were censored at the date of last assessment showing no degradation.</description>
          <population>Intent-to-treat population: all participants randomly assigned to study treatment.</population>
          <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="198"/>
                <count group_id="O2" value="198"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.4" lower_limit="6.3" upper_limit="11.4"/>
                    <measurement group_id="O2" value="8.3" lower_limit="6.1" upper_limit="11.1"/>
                  </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 or Other</non_inferiority_type>
            <p_value>0.4945</p_value>
            <p_value_desc>This secondary endpoint was not adjusted for multiple comparisons.</p_value_desc>
            <method>Log Rank</method>
            <method_desc>P-value is based on a log-rank test stratified by disease stage at study entry.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.910</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.695</ci_lower_limit>
            <ci_upper_limit>1.192</ci_upper_limit>
            <estimate_desc>Hazard ratio is based on a Cox regression model (with treatment as the only covariate) stratified by disease stage at study entry and is relative to bicalutamide with &lt; 1 favoring enzalutamide.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Best Overall Soft Tissue Response</title>
        <description>Best overall soft tissue response is defined as partial response (PR) or complete response (CR) while on study treatment based on investigator assessment of target, nontarget, and new lesions using RECIST 1.1. Only participants in the metastatic population with measurable soft tissue disease (at least 1 target lesion identified per RECIST 1.1) at screening were included in the analysis. All percentages are based on number of participants with metastatic and measurable soft tissue disease at screening in each treatment group.</description>
        <time_frame>From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.</time_frame>
        <population>All participants who were randomly assigned to study treatment and had metastatic and measurable soft tissue disease at screening.</population>
        <group_list>
          <group group_id="O1">
            <title>Enzalutamide</title>
            <description>Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule in DB phase.</description>
          </group>
          <group group_id="O2">
            <title>Bicalutamide</title>
            <description>Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules in DB phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Best Overall Soft Tissue Response</title>
          <description>Best overall soft tissue response is defined as partial response (PR) or complete response (CR) while on study treatment based on investigator assessment of target, nontarget, and new lesions using RECIST 1.1. Only participants in the metastatic population with measurable soft tissue disease (at least 1 target lesion identified per RECIST 1.1) at screening were included in the analysis. All percentages are based on number of participants with metastatic and measurable soft tissue disease at screening in each treatment group.</description>
          <population>All participants who were randomly assigned to study treatment and had metastatic and measurable soft tissue disease at screening.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.0" lower_limit="42.11" upper_limit="76.13"/>
                    <measurement group_id="O2" value="14.0" lower_limit="5.30" upper_limit="27.93"/>
                  </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 or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>This secondary endpoint was not adjusted for multiple comparisons.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Based on unstratified Cochran-Mantel-Haenszel mean score test.</method_desc>
            <param_type>Difference in objective response rate</param_type>
            <param_value>46.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>26.79</ci_lower_limit>
            <ci_upper_limit>65.30</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
        <description>An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. A treatment emergent AE defined as an event that emerged during treatment period (From first dose of study drug until end of open label phase [up to maximum duration of 65 months]) that was absent before treatment, or worsened during treatment period relative to pre-treatment state. AE included both serious and non- SAE. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An AE was considered related to study drug if event was assessed by investigator as probably or possibly related.</description>
        <time_frame>From first dose of study drug until the end of open label phase (up to maximum duration of 65 months)</time_frame>
        <population>Safety population included all participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Enzalutamide</title>
            <description>Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, and 1 bicalutamide matching placebo capsule once per day, by mouth for up to 29 months in DB phase. Participants who completed DB phase and consented to participate in open label phase, received enzalutamide 160 mg, self-administered as four 40-mg capsules once per day by mouth for up to 36 months in open label phase.</description>
          </group>
          <group group_id="O2">
            <title>DB Phase: Bicalutamide</title>
            <description>Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide matching placebo capsules for up to 29 months in DB phase.</description>
          </group>
          <group group_id="O3">
            <title>Open Label Phase: Bicalutamide Crossover to Enzalutamide</title>
            <description>Participants who received bicalutamide 50 mg in DB phase and consented to participate in open label phase, received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth in open label phase for up to 36 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
          <description>An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. A treatment emergent AE defined as an event that emerged during treatment period (From first dose of study drug until end of open label phase [up to maximum duration of 65 months]) that was absent before treatment, or worsened during treatment period relative to pre-treatment state. AE included both serious and non- SAE. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An AE was considered related to study drug if event was assessed by investigator as probably or possibly related.</description>
          <population>Safety population included all participants who received at least 1 dose of study drug.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="197"/>
                <count group_id="O2" value="198"/>
                <count group_id="O3" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.4"/>
                    <measurement group_id="O2" value="90.4"/>
                    <measurement group_id="O3" value="97.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AE Leading to Study Drug Discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.2"/>
                    <measurement group_id="O2" value="13.1"/>
                    <measurement group_id="O3" value="24.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AE Leading to Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6"/>
                    <measurement group_id="O2" value="3.0"/>
                    <measurement group_id="O3" value="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.6"/>
                    <measurement group_id="O2" value="30.3"/>
                    <measurement group_id="O3" value="43.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AE Related to Study Drug</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.5"/>
                    <measurement group_id="O2" value="53.5"/>
                    <measurement group_id="O3" value="70.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious AE Related to Study Drug</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6"/>
                    <measurement group_id="O2" value="3.5"/>
                    <measurement group_id="O3" value="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose of study drug until the end of open label phase (up to maximum duration of 65 months)</time_frame>
      <desc>Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study</desc>
      <group_list>
        <group group_id="E1">
          <title>Enzalutamide</title>
          <description>Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule for up to 29 months in DB phase. Participants who completed DB phase and consented to participate in open label phase, received same treatment for up to 36 months in open label phase.</description>
        </group>
        <group group_id="E2">
          <title>DB Phase: Bicalutamide</title>
          <description>Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules for up to 29 months in DB phase.</description>
        </group>
        <group group_id="E3">
          <title>Open Label Phase: Bicalutamide Crossover to Enzalutamide</title>
          <description>Participants who received bicalutamide 50 mg in DB phase and consented to participate in open label phase, received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth in open label phase for up to 36 months.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (16.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="76" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="60" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Lymphadenitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Aortic valve disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Atrioventricular block</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Stress cardiomyopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Ventricular fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Inappropriate antidiuretic hormone secretion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Diverticulum intestinal haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastric haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Large intestinal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Odynophagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Duodenal perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Device occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Disease progression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cholecystitis chronic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hepatic failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hepatitis B</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Lobar pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pulmonary sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Appendicitis perforated</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urinary bladder abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pubis fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urinary bladder rupture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Alcohol poisoning</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cystitis radiation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Ulna fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>International normalised ratio increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Troponin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypovolaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Intervertebral disc displacement</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pathological fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Spinal column stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Spondylolisthesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Bladder transitional cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Colon cancer metastatic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Erythroleukaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Intraductal papillary mucinous neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Metastases to adrenals</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Metastases to liver</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Metastases to spine</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Metastatic pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Myelofibrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Prostate cancer metastatic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Renal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of lung</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Transitional cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Tumour necrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Bladder cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cholangiocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Small cell lung cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Malignant melanoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Amnesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cervical cord compression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Convulsion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypoglycaemic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Metabolic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cognitive disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dyskinesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Haemorrhagic stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hydrocephalus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Bladder obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Bladder outlet obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Calculus bladder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Postrenal failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Renal failure acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Vesical fistula</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cystitis haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Obstructive uropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urethral stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Prostatic calcification</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis psoriasiform</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Umbilical hernia repair</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Accelerated hypertension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Aortic stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Peripheral artery thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (16.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="187" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="179" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="36" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Haemorrhagic anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Increased tendency to bruise</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Lymphadenitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Aortic valve disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Aortic valve stenosis</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis coronary artery</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Atrial thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Atrioventricular block second degree</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cardiomegaly</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Mitral valve incompetence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Sick sinus syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Ventricular extrasystoles</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cardiomyopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Branchial cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Phimosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Type V hyperlipidaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Cerumen impaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Deafness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Deafness bilateral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Ear discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Ear haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hearing impaired</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Otorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Vertigo positional</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Vestibular disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperparathyroidism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Inappropriate antidiuretic hormone secretion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Thyroid cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Astigmatism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cataract nuclear</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Diabetic retinopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Eye irritation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Eye pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Lacrimation increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Macular degeneration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Photophobia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Posterior capsule opacification</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Retinal tear</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Visual impairment</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Abdominal adhesions</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Abdominal hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Abdominal tenderness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Acquired oesophageal web</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Anal fissure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Bowel movement irregularity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Defaecation urgency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Diverticulum</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Duodenitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Erosive oesophagitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Faecal incontinence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Faeces discoloured</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Frequent bowel movements</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastric haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastritis haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastrointestinal angiodysplasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastrointestinal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gingival swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hiatus hernia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Impaired gastric emptying</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Mesenteric artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Mouth haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Oesophageal achalasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Oesophageal dilatation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Oesophageal disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Oesophageal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pancreatic atrophy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pancreatic cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Rectal discharge</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Rectal tenesmus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Retching</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Salivary hypersecretion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Tongue discolouration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Tongue ulceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Tooth loss</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="82" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="56" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Device dislocation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Device occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Early satiety</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Face oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Generalised oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Local swelling</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Localised oedema</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Suprapubic pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Temperature intolerance</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Thirst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gallbladder disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hepatic cirrhosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Liver injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Abscess soft tissue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Asymptomatic bacteriuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Axillary candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Bacterial disease carrier</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Bacteriuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Candida infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Chronic sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Furuncle</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Genital infection fungal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gingival infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Helicobacter infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hepatitis B</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Incision site infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Infected cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Kidney infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Klebsiella bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Lobar pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Mucosal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Onychomycosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Oropharyngitis fungal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Otitis externa</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Peripheral nerve infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Tinea infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Tinea pedis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urinary bladder abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Wound infection staphylococcal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </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" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Clavicle fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Compression fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Contrast media reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cystitis radiation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Eschar</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Excoriation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Facial bones fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Fibula fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Fractured coccyx</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Incision site pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Radiation injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Radiation pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Skeletal injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Spinal column injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Splinter</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Stress fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Thoracic vertebral fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Vth nerve injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Bone contusion</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Blood albumin decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Blood bicarbonate decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Blood calcium increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Blood cholesterol increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Blood lactic acid increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Blood parathyroid hormone increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Blood potassium increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Blood sodium decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Blood urine present</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cardiac murmur</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Face and mouth X-ray abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Helicobacter test positive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>International normalised ratio fluctuation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>International normalised ratio increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Intraocular pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Low density lipoprotein increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Lymphocyte count increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Neutrophil count increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Occult blood positive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Protein total decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Protein total increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Red blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Residual urine volume increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urine ketone body present</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urine leukocyte esterase positive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Vitamin D increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>White blood cell count increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Haematocrit decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Blood urea increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Acidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hyperchloraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypermagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypernatraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Increased appetite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Insulin resistance</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Iron deficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Lactic acidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Polydipsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Type 1 diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Vitamin B complex deficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Vitamin B12 deficiency</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Bunion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cervical spinal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Coccydynia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Costochondritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Exostosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Foot deformity</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Intervertebral disc compression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Intervertebral disc degeneration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Joint crepitation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Joint instability</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Joint stiffness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Limb discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Mobility decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Muscle atrophy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Muscle haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Muscle tightness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Muscle twitching</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Musculoskeletal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Musculoskeletal disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Osteolysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Osteopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Osteoporosis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pain in jaw</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pathological fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Plantar fasciitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Psoriatic arthropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Scoliosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Spinal column stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Spinal disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Spondylitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Spondylolisthesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Tendon disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Tendon pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Trigger finger</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Vertebral foraminal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Inguinal mass</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Benign salivary gland neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Bladder neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Colon adenoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Lipoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Metastases to bone</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Plasma cell myeloma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Renal oncocytoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Seborrhoeic keratosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Skin papilloma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Small cell lung cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Thyroid neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Tumour pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Altered state of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Amnesia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Aphasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Ataxia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Balance disorder</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Carotid artery occlusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cerebellar infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cervical radiculopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cognitive disorder</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dementia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Depressed level of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Diabetic neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Disturbance in attention</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dysaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Essential tremor</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypersomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypogeusia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hyposmia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Memory impairment</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Parkinson's disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Parosmia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Peroneal nerve palsy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Restless legs syndrome</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>VIIth nerve paralysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Visual field defect</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Vocal cord paralysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Muscle spasticity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Periodic limb movement disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Post-traumatic headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Abnormal dreams</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Alcoholism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Apathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Depressed mood</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Disorientation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Emotional distress</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hallucination</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Libido decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Mood altered</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Mood swings</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Nervousness</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Personality change</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Sleep terror</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Renal failure acute</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Bladder neck obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Bladder outlet obstruction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Bladder spasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Calculus bladder</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Chromaturia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cystitis noninfective</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Enuresis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Haemorrhage urinary tract</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypertonic bladder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Incontinence</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Microalbuminuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Micturition urgency</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Nocturia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Oliguria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pneumaturia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pyuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Renal cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Renal failure chronic</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Renal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Stress urinary incontinence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urethral haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urethral stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urethritis noninfective</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urge incontinence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urinary hesitation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urine flow decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Balanoposthitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Breast pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Breast tenderness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Erectile dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Genital discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Genital lesion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Genital rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gynaecomastia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Nipple pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Penile oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Penile swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Priapism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Prostatic pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Prostatomegaly</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Scrotal swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Testicular pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Alveolar lung disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Aspiration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dyspnoea paroxysmal nocturnal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Emphysema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Increased upper airway secretion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Nasal dryness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pulmonary fibrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pulmonary hypertension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pulmonary vascular disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Rales</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Respiratory disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Respiratory tract congestion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Rhonchi</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Sinus disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Sleep apnoea syndrome</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Upper-airway cough syndrome</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Actinic keratosis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Decubitus ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hair growth abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hyperkeratosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Ingrowing nail</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Lentigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pain of skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Photodermatosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pigmentation disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Rash generalised</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Rash macular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Skin discolouration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Skin disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Skin hypopigmentation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Swelling face</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Cataract operation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Skin neoplasm excision</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Accelerated hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Aortic arteriosclerosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Arteriovenous fistula</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Blood pressure inadequately controlled</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Intermittent claudication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Jugular vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Peripheral artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Peripheral coldness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Peripheral ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Peripheral vascular disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis superficial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Varicose vein</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Aortic aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>PI agrees not to independently publish the results before the publication of the multi-center PI paper. Sponsor shall review and comment 30 days prior to submission or disclosure. If publication or disclosure contains Sponsor Confidential Information, other than study data, PI agrees to remove Confidential Information from publication or disclosure. Sponsor may request that PI delay such publication for an additional 60 days to protect the patentability of any invention described.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer Inc.</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.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/NCT01664923
org study id: MDV3100-09
secondary id: C3431014
nct id: NCT01664923
lead sponsor: 
collaborator: 
collaborator: 
The purpose of this study is to determine the safety and efficacy of enzalutamide vs
      bicalutamide in asymptomatic or mildly symptomatic patients with prostate cancer who have
      disease progression despite primary androgen deprivation therapy.
This study is a multicenter phase 2, randomized, double-blind, efficacy and safety study of
      enzalutamide (160 mg/day) vs. bicalutamide (50 mg/day) in patients with recurrent prostate
      cancer who have serologic and/or radiographic disease progression despite primary androgen
      deprivation therapy.

      Throughout the study, safety and tolerability will be assessed by the recording of adverse
      events, monitoring of vital signs, physical examinations, and safety laboratory evaluations.

      Following study unblinding, study patients receiving enzalutamide or bicalutamide at the time
      of unblinding and qualifying patients randomized to bicalutamide who discontinued prior to
      unblinding will be offered the opportunity to receive open label enzalutamide treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Progression Free Survival (PFS)
time frame: From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.
description: PFS was defined as time from randomization to earliest objective evidence of prostate specific-antigen (PSA) progression, radiographic progression, or death on study. PSA progression was defined as ≥ 25% increase in PSA with an absolute increase ≥ 2 ng/mL above the nadir and was to be confirmed by a second consecutive assessment. Radiographic progression in bone was based on The Prostate Cancer Clinical Trials Working Group (PCWG2) guidelines defined as at least 2 new lesions on bone scan. Radiographic progression in soft tissue on Computerized Tomography/Magnetic Resonance Imaging (CT/MRI) was based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). CT/MRI and bone scans were read locally by the same radiologist (or nuclear medicine physician for interpretation of bone scans) whenever possible. Participants not known to have had a PFS event at the time of the analysis data cutoff were censored at the date of last assessment.
measure: Time to PSA Progression
time frame: From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.
description: PSA progression was defined as ≥ 25% increase in PSA with an absolute increase ≥ 2 ng/mL above the nadir and was to be confirmed by a second consecutive assessment at least 3 weeks later. Participants not known to have had PSA progression were censored at the date of last PSA assessment.
measure: Percentage of Participants With a PSA Response ≥ 50%
time frame: From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.
description: PSA response was defined as a reduction in PSA of at least 50% from baseline at any post baseline assessment confirmed by a second PSA assessment at least 3 weeks later.
measure: Duration of Radiographic PFS
time frame: From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.
description: Duration of radiographic PFS was defined as the time from randomization to the earliest objective evidence of radiographic disease progression or death on study and was to be evaluated for participants with metastatic disease at study entry. Radiographic disease progression in bone was based on PCWG2 guidelines defined as at least 2 new lesions on bone scan. Radiographic disease progression in soft tissue on CT/MRI was based on RECIST 1.1. CT/MRI and bone scans were read locally by the same radiologist (or nuclear medicine physician for interpretation of bone scans) whenever possible. Participants not known to have had radiographic progression at the time of analysis data cutoff were censored at the date of last radiographic assessment.
measure: Quality of Life: Time to Degradation of Functional Assessment of Cancer Therapy - Prostate (FACT-P)
time frame: From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.
description: The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess patient function in 4 domains: physical, social/family, emotional, and functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score (0 to 156) with higher scores representing better quality of life. Time to degradation of FACT-P was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the global FACT-P score for each participant. Participants with no score degradation at the time of analysis data cutoff were censored at the date of last assessment showing no degradation.
measure: Best Overall Soft Tissue Response
time frame: From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.
description: Best overall soft tissue response is defined as partial response (PR) or complete response (CR) while on study treatment based on investigator assessment of target, nontarget, and new lesions using RECIST 1.1. Only participants in the metastatic population with measurable soft tissue disease (at least 1 target lesion identified per RECIST 1.1) at screening were included in the analysis. All percentages are based on number of participants with metastatic and measurable soft tissue disease at screening in each treatment group.
measure: Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: From first dose of study drug until the end of open label phase (up to maximum duration of 65 months)
description: An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. A treatment emergent AE defined as an event that emerged during treatment period (From first dose of study drug until end of open label phase [up to maximum duration of 65 months]) that was absent before treatment, or worsened during treatment period relative to pre-treatment state. AE included both serious and non- SAE. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An AE was considered related to study drug if event was assessed by investigator as probably or possibly related.
arm group label: Enzalutamide
arm group type: Experimental
description: Enzalutamide 160 mg/day orally
arm group label: Bicalutamide
arm group type: Active Comparator
description: 50 mg/day orally
intervention type: Drug
intervention name: Enzalutamide
description: 160 mg, daily, by mouth.
arm group label: Enzalutamide
other name: MDV3100
other name: Xtandi
intervention type: Drug
intervention name: Bicalutamide
description: 50 mg, daily, by mouth
arm group label: Bicalutamide
other name: Casodex
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Bicalutamide
sharing ipd: Yes
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
ipd url: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 