<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/NCT03264066</url>
  </required_header>
  <id_info>
    <org_study_id>WO39760</org_study_id>
    <secondary_id>2017-000794-37</secondary_id>
    <nct_id>NCT03264066</nct_id>
  </id_info>
  <brief_title>A Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab in Participants With Solid Tumors</brief_title>
  <official_title>A Phase II, Open-Label, Multicenter, Multicohort Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab in Patients With Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study to evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus&#xD;
      atezolizumab in participants with advanced solid tumors including the following cohorts:&#xD;
      squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma (UC), and renal&#xD;
      cell carcinoma (RCC).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 23, 2017</start_date>
  <completion_date type="Actual">June 25, 2020</completion_date>
  <primary_completion_date type="Actual">June 25, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>Up to approximately 31 months</time_frame>
    <description>Objective response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive tumor assessments ≥4 weeks apart, as determined by the investigators using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to approximately 31 months</time_frame>
    <description>Overall survival was defined as the time from enrollment to death from any cause. The median for OS is Kaplan-Meier estimate. 95% CI for median was computed using the method of Brookmeyer and Crowley.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>Up to approximately 31 months</time_frame>
    <description>PFS was defined as the time from enrollment to the first occurrence of disease progression as determined by the investigator(s), using RECIST v1.1, or to death from any cause, whichever occurs first. Disease progression was defined as ≥20% increase in in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>Up to approximately 22 months</time_frame>
    <description>DOR was defined as the time from the first occurrence of a documented, confirmed objective response to disease progression as determined by the investigator, using RECIST v1.1, or to death from any cause, whichever occurs first. Objective response was defined as a complete response (CR) or a partial response (PR) on two consecutive tumor assessments ≥4 weeks apart. CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions. Disease progression was defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions. Presented here is median DOR at the time of primary analysis. The median for the duration of response is Kaplan-Meier estimate. 95% CI for median was computed using the method of Brookmeyer and Crowley.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR)</measure>
    <time_frame>At 16 weeks</time_frame>
    <description>DCR was defined as the percentage of participants with a complete response (CR), a partial response (PR), or stable disease at 16 weeks as determined by the investigator using RECIST v1.1. CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions. Stable disease was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for disease progression. Disease progression was defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events</measure>
    <time_frame>Up to approximately 31 months</time_frame>
    <description>An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Plasma Concentration (Cmax) of Cobimetinib</measure>
    <time_frame>Day 15 of Cycle 3 (cycle is 28 days): 2-4 hours after cobimetinib dose</time_frame>
    <description>Cmax is the maximum (or peak) concentration that a study drug achieves in the body.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum Plasma Concentration (Cmin) of Cobimetinib</measure>
    <time_frame>Day 15 of Cycle 3 (cycle is 28 days): prior to cobimetinib dose</time_frame>
    <description>Cmin is the minimum (or trough) concentration that a study drug achieves in the body.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Serum Concentration (Cmax) of Atezolizumab</measure>
    <time_frame>30 minutes following end of atezolizumab infusion on Day 15 of Cycle 3 (each cycle is 28 days)</time_frame>
    <description>Cmax is the maximum (or peak) concentration that a study drug achieves in the body.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum Serum Concentration (Cmin) of Atezolizumab</measure>
    <time_frame>Prior to atezolizumab infusion on Day 1 of Cycles (each cycle is 28 days) 2, 4, 8, 12, and 16, Day 15 of Cycle 3</time_frame>
    <description>Cmin is the minimum (or trough) concentration that a study drug achieves in the body.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Anti-drug Antibodies (ADAs)</measure>
    <time_frame>Day 1 of Cycles (each cycle is 28 days) 1, 2, 4, 8, 12, and 16; Day 15 of Cycle 3; at atezolizumab treatment discontinuation visit, and &lt;90 days after last atezolizumab infusion (up to approximately 31 months)</time_frame>
    <description>Participants were considered to be ADA positive if they were missing data at baseline but developed an ADA response following study drug administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 4-fold greater (i.e., ≥0.60-titer units) than the titer of the baseline sample (treatment-enhanced ADA response). Participants were considered to be ADA negative if they were missing data at baseline, had a post-baseline ADA result, and all post-baseline samples were negative, or if they were ADA positive at baseline but did not have any post-baseline samples with a titer that was at least 4-fold greater than the titer of the baseline sample (treatment unaffected).</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">87</enrollment>
  <condition>Solid Tumors</condition>
  <arm_group>
    <arm_group_label>Cohort 1 - SCCHN - Treatment Naive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In participants with recurrent or advanced / metastatic SSCHN who are anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 - UC - Treatment Naive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In participants with advanced / metastatic UC who are anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3 - RCC - Treatment Naive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In participants with metastatic RCC who are anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib will be administered at the approved dose and schedule of 60 milligrams (mg) once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4 - SCCHN - Previous Treatment Exposure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In participants with SCCHN whose disease has progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 5 - UC - Previous Treatment Exposure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In participants with UC whose disease has progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 6 - RCC - Previous Treatment Exposure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In participants with RCC whose disease has progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 7 - Biopsy Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In participants with solid non-melanoma, non- hematologic tumors who previously developed primary or secondary resistance to an anti-PD-1 or anti-PD-L1 agent, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle. The first dose of atezolizumab of 840 mg by IV infusions on Day 15 of Cycle 1. Thereafter, they will receive atezolizumab 840 mg IV infusion Q2W on Days 1 and 15 of Cycle 2 and all subsequent cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cobimetinib</intervention_name>
    <description>Participants will receive cobimetinib 60 mg (3 tablets of 20 mg each) orally once a day on Days 1-21 of each 28-day cycle.</description>
    <arm_group_label>Cohort 1 - SCCHN - Treatment Naive</arm_group_label>
    <arm_group_label>Cohort 2 - UC - Treatment Naive</arm_group_label>
    <arm_group_label>Cohort 3 - RCC - Treatment Naive</arm_group_label>
    <arm_group_label>Cohort 4 - SCCHN - Previous Treatment Exposure</arm_group_label>
    <arm_group_label>Cohort 5 - UC - Previous Treatment Exposure</arm_group_label>
    <arm_group_label>Cohort 6 - RCC - Previous Treatment Exposure</arm_group_label>
    <arm_group_label>Cohort 7 - Biopsy Cohort</arm_group_label>
    <other_name>Cotellic</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atezolizumab</intervention_name>
    <description>Atezolizumab will be given at a fixed dose of 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.</description>
    <arm_group_label>Cohort 1 - SCCHN - Treatment Naive</arm_group_label>
    <arm_group_label>Cohort 2 - UC - Treatment Naive</arm_group_label>
    <arm_group_label>Cohort 3 - RCC - Treatment Naive</arm_group_label>
    <arm_group_label>Cohort 4 - SCCHN - Previous Treatment Exposure</arm_group_label>
    <arm_group_label>Cohort 5 - UC - Previous Treatment Exposure</arm_group_label>
    <arm_group_label>Cohort 6 - RCC - Previous Treatment Exposure</arm_group_label>
    <other_name>Tecentriq</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atezolizumab Cohort 7</intervention_name>
    <description>Only for participants in cohort 7, the first dose of atezolizumab of 840 mg will be given by IV infusion on Day 15 of Cycle 1; thereafter, they will receive atezolizumab 840 mg IV infusion Q2W on Days 1 and 15 of Cycle 2 and all subsequent cycles.</description>
    <arm_group_label>Cohort 7 - Biopsy Cohort</arm_group_label>
    <other_name>Tecentriq</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        General Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Ability to comply with the study protocol, in the investigator's judgment&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1&#xD;
&#xD;
          -  Life expectancy ≥3 months, as determined by the investigator&#xD;
&#xD;
          -  Adequate hematologic and end-organ function&#xD;
&#xD;
        Cancer-Related Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have measurable disease by computed tomography (CT) or magnetic&#xD;
             resonance imaging (MRI) scan per RECIST v1.1.&#xD;
&#xD;
          -  Availability to provide a representative tumor specimen biopsy&#xD;
&#xD;
          -  Evidence of tumor progression on or after the last treatment regimen received and&#xD;
             within 6 months prior to study enrollment&#xD;
&#xD;
          -  For women of childbearing potential: agreement to remain abstinent (refrain from&#xD;
             heterosexual intercourse) or use a non-hormonal contraceptive method with a failure&#xD;
             rate of &lt;1% per year during the treatment period and for at least 5 months after the&#xD;
             last dose of atezolizumab and within 3 months after the last dose of cobimetinib&#xD;
&#xD;
          -  For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use&#xD;
             contraceptive measures, and agreement to refrain from donating sperm during the&#xD;
             treatment period and for at least 3 months after the last dose of cobimetinib&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        General Exclusion Criteria:&#xD;
&#xD;
          -  Inability to swallow medications&#xD;
&#xD;
          -  Malabsorption condition that would alter the absorption of orally administered&#xD;
             medications&#xD;
&#xD;
          -  Poor peripheral venous access&#xD;
&#xD;
          -  Prior treatment with cobimetinib or a MEK inhibitor&#xD;
&#xD;
          -  Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies,&#xD;
             including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies&#xD;
&#xD;
          -  Treatment with investigational therapy within 14 days prior to initiation of study&#xD;
             treatment&#xD;
&#xD;
          -  Any anti-cancer therapy, including chemotherapy or hormonal therapy, within 2 weeks&#xD;
             prior to initiation of study treatment&#xD;
&#xD;
          -  History of severe allergic, anaphylactic, or other hypersensitivity reactions to&#xD;
             chimeric or humanized antibodies or fusion proteins&#xD;
&#xD;
          -  Known hypersensitivity to biopharmaceutical agents produced in Chinese hamster ovary&#xD;
             cells or any component of the atezolizumab formulation, or any component of the&#xD;
             cobimetinib formulation&#xD;
&#xD;
          -  History of serous retinopathy, retinal vein occlusion (RVO), or evidence of ongoing&#xD;
             serous retinopathy or RVO at baseline&#xD;
&#xD;
          -  Major surgical procedure other than for diagnosis within 4 weeks prior to initiation&#xD;
             of study treatment, or anticipation of need for a major surgical procedure during the&#xD;
             study&#xD;
&#xD;
          -  Uncontrolled tumor-related pain&#xD;
&#xD;
          -  Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated&#xD;
             drainage more than once every 28 days&#xD;
&#xD;
          -  Uncontrolled hypercalcemia (ionized calcium &gt;1.5 millimoles per liter [mmol/L],&#xD;
             calcium &gt;12 milligrams per deciliter [mg/dL], or corrected calcium greater than the&#xD;
             upper limit of normal [ULN]) or symptomatic hypercalcemia requiring continued use of&#xD;
             bisphosphonate therapy&#xD;
&#xD;
          -  Active or untreated central nervous system (CNS) metastases&#xD;
&#xD;
          -  Pregnancy or breastfeeding, or intending to become pregnant during the study&#xD;
&#xD;
        Exclusion Criteria based on Organ Function or Medical History&#xD;
&#xD;
        Cardiovascular&#xD;
&#xD;
        Patients who meet the following cardiovascular exclusion criterion will be excluded from&#xD;
        study entry:&#xD;
&#xD;
          -  Left ventricular ejection fraction (LVEF) below the institutional lower limit of&#xD;
             normal or &lt;50%, whichever is lower&#xD;
&#xD;
        Infections Patients who meet any of the following infection exclusion criteria will be&#xD;
        excluded from study entry:&#xD;
&#xD;
          -  Positive human immunodeficiency virus (HIV) test at screening&#xD;
&#xD;
          -  Active hepatitis B virus (HBV) infection (chronic or acute)&#xD;
&#xD;
          -  Active hepatitis C virus (HCV) infection&#xD;
&#xD;
          -  Active tuberculosis&#xD;
&#xD;
          -  Severe infection within 4 weeks prior to initiation of study treatment, including, but&#xD;
             not limited to, hospitalization for complications of infection, bacteremia, or severe&#xD;
             pneumonia&#xD;
&#xD;
          -  Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation&#xD;
             of study treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Georgetown University Medical Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansas City - Menorah Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan-Kettering Cancer Center</name>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <zip>11725</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering - Basking Ridge</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarah Cannon Research Institute</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Groeninge</name>
      <address>
        <city>Kortrijk</city>
        <zip>8500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Tübingen; Klinik für Urologie</name>
      <address>
        <city>Tübingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orszagos Onkologiai Intezet</name>
      <address>
        <city>Budapest</city>
        <zip>1122</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem Klinikai Kozpont</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jósa András Oktatókórház</name>
      <address>
        <city>Nyíregyháza</city>
        <zip>4400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>(0)6351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yonsei Cancer Center</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barts &amp; London School of Med; Medical Oncology</name>
      <address>
        <city>London</city>
        <zip>EC1A 7BE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Marsden Hospital - Fulham</name>
      <address>
        <city>London</city>
        <zip>SW3 6JJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Marsden</name>
      <address>
        <city>London</city>
        <zip>SW7 3RP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Korea, Republic of</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <results_first_submitted>December 23, 2020</results_first_submitted>
  <results_first_submitted_qc>February 9, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 1, 2021</results_first_posted>
  <disposition_first_submitted>June 16, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>February 9, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">March 1, 2021</disposition_first_posted>
  <last_update_submitted>April 20, 2021</last_update_submitted>
  <last_update_submitted_qc>April 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atezolizumab</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 18, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT03264066/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Enrollment took place in six countries: Republic of Korea, Belgium, Germany, United Kingdom, Hungary and United States. No participants were enrolled in Cohort 7. Participants in long term follow up and who continued to receive treatment(s) in a post-trial access program are designated in Participant Flow as &quot;Study terminated by Sponsor&quot;.</recruitment_details>
      <pre_assignment_details>Participants with advanced solid tumors were included in the study: squamous cell carcinoma of head and neck (SCCHN), urothelial carcinoma (UC), and renal cell carcinoma (RCC).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cohort 1 - SCCHN - Treatment Naive</title>
          <description>In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.</description>
        </group>
        <group group_id="P2">
          <title>Cohort 2 - UC - Treatment Naive</title>
          <description>In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
        </group>
        <group group_id="P3">
          <title>Cohort 3 - RCC - Treatment Naive</title>
          <description>In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
        </group>
        <group group_id="P4">
          <title>Cohort 4 - SCCHN - Previous Treatment Exposure</title>
          <description>In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
        </group>
        <group group_id="P5">
          <title>Cohort 5 - UC - Previous Treatment Exposure</title>
          <description>In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
        </group>
        <group group_id="P6">
          <title>Cohort 6 - RCC - Previous Treatment Exposure</title>
          <description>In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="17"/>
                <participants group_id="P4" count="20"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="17"/>
                <participants group_id="P4" count="20"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="10"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive Disease</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The intent-to-treat (ITT) population included all participants enrolled in the study.</population>
      <group_list>
        <group group_id="B1">
          <title>Cohort 1 - SCCHN - Treatment Naive</title>
          <description>In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.</description>
        </group>
        <group group_id="B2">
          <title>Cohort 2 - UC - Treatment Naive</title>
          <description>In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
        </group>
        <group group_id="B3">
          <title>Cohort 3 - RCC - Treatment Naive</title>
          <description>In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
        </group>
        <group group_id="B4">
          <title>Cohort 4 - SCCHN - Previous Treatment Exposure</title>
          <description>In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
        </group>
        <group group_id="B5">
          <title>Cohort 5 - UC - Previous Treatment Exposure</title>
          <description>In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
        </group>
        <group group_id="B6">
          <title>Cohort 6 - RCC - Previous Treatment Exposure</title>
          <description>In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
        </group>
        <group group_id="B7">
          <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="20"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="17"/>
            <count group_id="B4" value="20"/>
            <count group_id="B5" value="7"/>
            <count group_id="B6" value="3"/>
            <count group_id="B7" value="87"/>
          </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>Adults (18-64 years)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>From 65-84 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="19"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="19"/>
                    <measurement group_id="B5" value="7"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Objective Response Rate (ORR)</title>
        <description>Objective response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive tumor assessments ≥4 weeks apart, as determined by the investigators using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions.</description>
        <time_frame>Up to approximately 31 months</time_frame>
        <population>The intent-to-treat (ITT) population included all participants enrolled in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 - SCCHN - Treatment Naive</title>
            <description>In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2 - UC - Treatment Naive</title>
            <description>In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3 - RCC - Treatment Naive</title>
            <description>In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4 - SCCHN - Previous Treatment Exposure</title>
            <description>In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O5">
            <title>Cohort 5 - UC - Previous Treatment Exposure</title>
            <description>In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 6 - RCC - Previous Treatment Exposure</title>
            <description>In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR)</title>
          <description>Objective response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive tumor assessments ≥4 weeks apart, as determined by the investigators using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions.</description>
          <population>The intent-to-treat (ITT) population included all participants enrolled in the study.</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="20"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="20"/>
                <count group_id="O5" value="7"/>
                <count group_id="O6" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0" lower_limit="0.00" upper_limit="40.03"/>
                    <measurement group_id="O2" value="30.0" lower_limit="7.42" upper_limit="52.58"/>
                    <measurement group_id="O3" value="17.6" lower_limit="0.00" upper_limit="38.71"/>
                    <measurement group_id="O4" value="0" lower_limit="0.00" upper_limit="2.50"/>
                    <measurement group_id="O5" value="0" lower_limit="0.00" upper_limit="7.14"/>
                    <measurement group_id="O6" value="0" lower_limit="0.00" upper_limit="16.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>Overall survival was defined as the time from enrollment to death from any cause. The median for OS is Kaplan-Meier estimate. 95% CI for median was computed using the method of Brookmeyer and Crowley.</description>
        <time_frame>Up to approximately 31 months</time_frame>
        <population>The ITT population included all participants enrolled in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 - SCCHN - Treatment Naive</title>
            <description>In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2 - UC - Treatment Naive</title>
            <description>In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3 - RCC - Treatment Naive</title>
            <description>In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4 - SCCHN - Previous Treatment Exposure</title>
            <description>In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O5">
            <title>Cohort 5 - UC - Previous Treatment Exposure</title>
            <description>In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 6 - RCC - Previous Treatment Exposure</title>
            <description>In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>Overall survival was defined as the time from enrollment to death from any cause. The median for OS is Kaplan-Meier estimate. 95% CI for median was computed using the method of Brookmeyer and Crowley.</description>
          <population>The ITT population included all participants enrolled in the study.</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="20"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="20"/>
                <count group_id="O5" value="7"/>
                <count group_id="O6" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.8" lower_limit="6.9" upper_limit="25.8"/>
                    <measurement group_id="O2" value="18.7" lower_limit="11.0" upper_limit="26.2"/>
                    <measurement group_id="O3" value="21.7" lower_limit="17.4" upper_limit="NA">NA=not estimable</measurement>
                    <measurement group_id="O4" value="7.7" lower_limit="4.0" upper_limit="NA">NA=not estimable</measurement>
                    <measurement group_id="O5" value="5.9" lower_limit="3.1" upper_limit="12.5"/>
                    <measurement group_id="O6" value="NA" lower_limit="5.9" upper_limit="NA">NA=not estimable</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-Free Survival (PFS)</title>
        <description>PFS was defined as the time from enrollment to the first occurrence of disease progression as determined by the investigator(s), using RECIST v1.1, or to death from any cause, whichever occurs first. Disease progression was defined as ≥20% increase in in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions.</description>
        <time_frame>Up to approximately 31 months</time_frame>
        <population>The ITT population included all participants enrolled in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 - SCCHN - Treatment Naive</title>
            <description>In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2 - UC - Treatment Naive</title>
            <description>In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3 - RCC - Treatment Naive</title>
            <description>In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4 - SCCHN - Previous Treatment Exposure</title>
            <description>In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O5">
            <title>Cohort 5 - UC - Previous Treatment Exposure</title>
            <description>In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 6 - RCC - Previous Treatment Exposure</title>
            <description>In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-Free Survival (PFS)</title>
          <description>PFS was defined as the time from enrollment to the first occurrence of disease progression as determined by the investigator(s), using RECIST v1.1, or to death from any cause, whichever occurs first. Disease progression was defined as ≥20% increase in in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions.</description>
          <population>The ITT population included all participants enrolled in the study.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="20"/>
                <count group_id="O5" value="7"/>
                <count group_id="O6" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" lower_limit="2" upper_limit="26"/>
                    <measurement group_id="O2" value="3.4" lower_limit="2" upper_limit="26"/>
                    <measurement group_id="O3" value="3.4" lower_limit="1" upper_limit="28"/>
                    <measurement group_id="O4" value="3.6" lower_limit="0" upper_limit="9"/>
                    <measurement group_id="O5" value="2.1" lower_limit="1" upper_limit="4"/>
                    <measurement group_id="O6" value="2.7" lower_limit="1" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DOR)</title>
        <description>DOR was defined as the time from the first occurrence of a documented, confirmed objective response to disease progression as determined by the investigator, using RECIST v1.1, or to death from any cause, whichever occurs first. Objective response was defined as a complete response (CR) or a partial response (PR) on two consecutive tumor assessments ≥4 weeks apart. CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions. Disease progression was defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions. Presented here is median DOR at the time of primary analysis. The median for the duration of response is Kaplan-Meier estimate. 95% CI for median was computed using the method of Brookmeyer and Crowley.</description>
        <time_frame>Up to approximately 22 months</time_frame>
        <population>ITT population: all participants enrolled in the study. Median DOR is presented at the time of primary analysis. DOR analyses were not performed at final analysis because Kaplan-Meier was not estimable at primary analysis due to too few events in Cohorts 1 and 3. There were no subsequent events in Cohorts 1 and 3. Cohorts 4-6 had no events.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 - SCCHN - Treatment Naive</title>
            <description>In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2 - UC - Treatment Naive</title>
            <description>In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3 - RCC - Treatment Naive</title>
            <description>In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4 - SCCHN - Previous Treatment Exposure</title>
            <description>In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O5">
            <title>Cohort 5 - UC - Previous Treatment Exposure</title>
            <description>In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 6 - RCC - Previous Treatment Exposure</title>
            <description>In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response (DOR)</title>
          <description>DOR was defined as the time from the first occurrence of a documented, confirmed objective response to disease progression as determined by the investigator, using RECIST v1.1, or to death from any cause, whichever occurs first. Objective response was defined as a complete response (CR) or a partial response (PR) on two consecutive tumor assessments ≥4 weeks apart. CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions. Disease progression was defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions. Presented here is median DOR at the time of primary analysis. The median for the duration of response is Kaplan-Meier estimate. 95% CI for median was computed using the method of Brookmeyer and Crowley.</description>
          <population>ITT population: all participants enrolled in the study. Median DOR is presented at the time of primary analysis. DOR analyses were not performed at final analysis because Kaplan-Meier was not estimable at primary analysis due to too few events in Cohorts 1 and 3. There were no subsequent events in Cohorts 1 and 3. Cohorts 4-6 had no events.</population>
          <units>days</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="20"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">NA=not estimable: Kaplan-Meier was not estimable because there were too few events in Cohort 1.</measurement>
                    <measurement group_id="O2" value="149.0" lower_limit="125.0" upper_limit="173.0"/>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">NA=not estimable: Kaplan-Meier was not estimable because there were too few events in Cohort 3.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Control Rate (DCR)</title>
        <description>DCR was defined as the percentage of participants with a complete response (CR), a partial response (PR), or stable disease at 16 weeks as determined by the investigator using RECIST v1.1. CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions. Stable disease was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for disease progression. Disease progression was defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions.</description>
        <time_frame>At 16 weeks</time_frame>
        <population>The ITT population included all participants enrolled in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 - SCCHN - Treatment Naive</title>
            <description>In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2 - UC - Treatment Naive</title>
            <description>In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3 - RCC - Treatment Naive</title>
            <description>In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4 - SCCHN - Previous Treatment Exposure</title>
            <description>In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O5">
            <title>Cohort 5 - UC - Previous Treatment Exposure</title>
            <description>In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 6 - RCC - Previous Treatment Exposure</title>
            <description>In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Control Rate (DCR)</title>
          <description>DCR was defined as the percentage of participants with a complete response (CR), a partial response (PR), or stable disease at 16 weeks as determined by the investigator using RECIST v1.1. CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions. Stable disease was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for disease progression. Disease progression was defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions.</description>
          <population>The ITT population included all participants enrolled in the study.</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="20"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="20"/>
                <count group_id="O5" value="7"/>
                <count group_id="O6" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" lower_limit="25.59" upper_limit="74.41"/>
                    <measurement group_id="O2" value="40.0" lower_limit="16.03" upper_limit="63.97"/>
                    <measurement group_id="O3" value="23.5" lower_limit="0.42" upper_limit="46.63"/>
                    <measurement group_id="O4" value="25.0" lower_limit="3.52" upper_limit="46.48"/>
                    <measurement group_id="O5" value="0" lower_limit="0.00" upper_limit="7.14"/>
                    <measurement group_id="O6" value="0" lower_limit="0.00" upper_limit="16.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events</title>
        <description>An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.</description>
        <time_frame>Up to approximately 31 months</time_frame>
        <population>The safety population included all enrolled participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 - SCCHN - Treatment Naive</title>
            <description>In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2 - UC - Treatment Naive</title>
            <description>In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3 - RCC - Treatment Naive</title>
            <description>In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4 - SCCHN - Previous Treatment Exposure</title>
            <description>In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O5">
            <title>Cohort 5 - UC - Previous Treatment Exposure</title>
            <description>In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 6 - RCC - Previous Treatment Exposure</title>
            <description>In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events</title>
          <description>An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.</description>
          <population>The safety population included all enrolled participants who received at least one dose of study drug.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="20"/>
                <count group_id="O5" value="7"/>
                <count group_id="O6" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="17"/>
                    <measurement group_id="O4" value="20"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Plasma Concentration (Cmax) of Cobimetinib</title>
        <description>Cmax is the maximum (or peak) concentration that a study drug achieves in the body.</description>
        <time_frame>Day 15 of Cycle 3 (cycle is 28 days): 2-4 hours after cobimetinib dose</time_frame>
        <population>Pharmacokinetic (PK) analysis population consisted of participants with sufficient data to enable estimation of key parameters, with participants grouped according to treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohorts 1-6</title>
            <description>In all participants cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Plasma Concentration (Cmax) of Cobimetinib</title>
          <description>Cmax is the maximum (or peak) concentration that a study drug achieves in the body.</description>
          <population>Pharmacokinetic (PK) analysis population consisted of participants with sufficient data to enable estimation of key parameters, with participants grouped according to treatment received.</population>
          <units>nanogram per milliliter (ng/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="285" spread="56.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Minimum Plasma Concentration (Cmin) of Cobimetinib</title>
        <description>Cmin is the minimum (or trough) concentration that a study drug achieves in the body.</description>
        <time_frame>Day 15 of Cycle 3 (cycle is 28 days): prior to cobimetinib dose</time_frame>
        <population>PK analysis population consisted of participants with sufficient data to enable estimation of key parameters, with participants grouped according to treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohorts 1-6</title>
            <description>In all participants cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Minimum Plasma Concentration (Cmin) of Cobimetinib</title>
          <description>Cmin is the minimum (or trough) concentration that a study drug achieves in the body.</description>
          <population>PK analysis population consisted of participants with sufficient data to enable estimation of key parameters, with participants grouped according to treatment received.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="174" spread="152"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Serum Concentration (Cmax) of Atezolizumab</title>
        <description>Cmax is the maximum (or peak) concentration that a study drug achieves in the body.</description>
        <time_frame>30 minutes following end of atezolizumab infusion on Day 15 of Cycle 3 (each cycle is 28 days)</time_frame>
        <population>PK analysis population consisted of participants with sufficient data to enable estimation of key parameters, with participants grouped according to treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohorts 1-6</title>
            <description>In all participants cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Serum Concentration (Cmax) of Atezolizumab</title>
          <description>Cmax is the maximum (or peak) concentration that a study drug achieves in the body.</description>
          <population>PK analysis population consisted of participants with sufficient data to enable estimation of key parameters, with participants grouped according to treatment received.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="417000" spread="50.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Minimum Serum Concentration (Cmin) of Atezolizumab</title>
        <description>Cmin is the minimum (or trough) concentration that a study drug achieves in the body.</description>
        <time_frame>Prior to atezolizumab infusion on Day 1 of Cycles (each cycle is 28 days) 2, 4, 8, 12, and 16, Day 15 of Cycle 3</time_frame>
        <population>PK analysis population consisted of participants with sufficient data to enable estimation of key parameters, with participants grouped according to treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohorts 1-6</title>
            <description>In all participants cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Minimum Serum Concentration (Cmin) of Atezolizumab</title>
          <description>Cmin is the minimum (or trough) concentration that a study drug achieves in the body.</description>
          <population>PK analysis population consisted of participants with sufficient data to enable estimation of key parameters, with participants grouped according to treatment received.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112000" spread="219"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Anti-drug Antibodies (ADAs)</title>
        <description>Participants were considered to be ADA positive if they were missing data at baseline but developed an ADA response following study drug administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 4-fold greater (i.e., ≥0.60-titer units) than the titer of the baseline sample (treatment-enhanced ADA response). Participants were considered to be ADA negative if they were missing data at baseline, had a post-baseline ADA result, and all post-baseline samples were negative, or if they were ADA positive at baseline but did not have any post-baseline samples with a titer that was at least 4-fold greater than the titer of the baseline sample (treatment unaffected).</description>
        <time_frame>Day 1 of Cycles (each cycle is 28 days) 1, 2, 4, 8, 12, and 16; Day 15 of Cycle 3; at atezolizumab treatment discontinuation visit, and &lt;90 days after last atezolizumab infusion (up to approximately 31 months)</time_frame>
        <population>The safety population included all enrolled participants who received at least one dose of study drug. Number analyzed is the number of participants with data available for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 - SCCHN - Treatment Naive</title>
            <description>In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2 - UC - Treatment Naive</title>
            <description>In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3 - RCC - Treatment Naive</title>
            <description>In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4 - SCCHN - Previous Treatment Exposure</title>
            <description>In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O5">
            <title>Cohort 5 - UC - Previous Treatment Exposure</title>
            <description>In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 6 - RCC - Previous Treatment Exposure</title>
            <description>In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Anti-drug Antibodies (ADAs)</title>
          <description>Participants were considered to be ADA positive if they were missing data at baseline but developed an ADA response following study drug administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 4-fold greater (i.e., ≥0.60-titer units) than the titer of the baseline sample (treatment-enhanced ADA response). Participants were considered to be ADA negative if they were missing data at baseline, had a post-baseline ADA result, and all post-baseline samples were negative, or if they were ADA positive at baseline but did not have any post-baseline samples with a titer that was at least 4-fold greater than the titer of the baseline sample (treatment unaffected).</description>
          <population>The safety population included all enrolled participants who received at least one dose of study drug. Number analyzed is the number of participants with data available for analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to approximately 31 months</time_frame>
      <desc>The safety population included all enrolled participants who received at least one dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cohort 1 - SCCHN - Treatment Naive</title>
          <description>In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.</description>
        </group>
        <group group_id="E2">
          <title>Cohort 2 - UC - Treatment Naive</title>
          <description>In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
        </group>
        <group group_id="E3">
          <title>Cohort 3 - RCC - Treatment Naive</title>
          <description>In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
        </group>
        <group group_id="E4">
          <title>Cohort 4 - SCCHN - Previous Treatment Exposure</title>
          <description>In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
        </group>
        <group group_id="E5">
          <title>Cohort 5 - UC - Previous Treatment Exposure</title>
          <description>In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
        </group>
        <group group_id="E6">
          <title>Cohort 6 - RCC - Previous Treatment Exposure</title>
          <description>In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>ANAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ATRIAL FIBRILLATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PERICARDITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>COLITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>DYSPHAGIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>ENTEROCOLITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>GASTRITIS EROSIVE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>ILEUS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>INTESTINAL OBSTRUCTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>LARGE INTESTINAL OBSTRUCTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>LARGE INTESTINE PERFORATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PNEUMATOSIS INTESTINALIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>RECTAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>UPPER GASTROINTESTINAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>ASTHENIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>CHILLS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>FACE OEDEMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>GENERAL PHYSICAL HEALTH DETERIORATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PYREXIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>IMMUNE-MEDIATED HEPATITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>DEVICE RELATED SEPSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>ENDOCARDITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>LOWER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PHARYNGITIS STREPTOCOCCAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PNEUMONIA</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>SEPSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>HUMERUS FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>INFUSION RELATED REACTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>POSTOPERATIVE RESPIRATORY FAILURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>ALANINE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>ASPARTATE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>EJECTION FRACTION DECREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>TUMOUR HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>ALTERED STATE OF CONSCIOUSNESS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>IMMUNE-MEDIATED ENCEPHALITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>DEVICE DISLOCATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>NEPHRITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>URINARY RETENTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>DYSPNOEA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PLEURAL EFFUSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PNEUMONIA ASPIRATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PNEUMONITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PULMONARY EMBOLISM</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>RESPIRATORY TRACT OEDEMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>RASH</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>RASH MACULAR</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>RASH MACULO-PAPULAR</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>GASTROSTOMY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HYPOTENSION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="19" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>ANAEMIA</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="20"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="19"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="17"/>
                <counts group_id="E4" events="4" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>IRON DEFICIENCY ANAEMIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>LEUKOCYTOSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>LEUKOPENIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>LYMPH NODE PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>LYMPHADENITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>LYMPHOPENIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>NEUTROPENIA</sub_title>
                <counts group_id="E1" events="7" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>THROMBOCYTOPENIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ATRIAL FIBRILLATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>ATRIOVENTRICULAR BLOCK FIRST DEGREE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>CARDIAC FAILURE CONGESTIVE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>CORONARY ARTERY DISEASE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PERICARDITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>SINUS BRADYCARDIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>SINUS TACHYCARDIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>TACHYCARDIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>VENTRICULAR DYSFUNCTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>HYPOACUSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>INNER EAR DISORDER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>VERTIGO</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERTHYROIDISM</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>HYPOTHYROIDISM</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>THYROIDITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>CATARACT</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>CHORIORETINOPATHY</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>ENTROPION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>EYELID OEDEMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>EYELID PTOSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>GLAUCOMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>LACRIMATION INCREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>MACULAR OEDEMA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>OPTIC NERVE DISORDER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PERIORBITAL OEDEMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>RETINAL OEDEMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>RETINOPATHY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>SUBRETINAL FLUID</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>SWELLING OF EYELID</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>TRICHIASIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>VISION BLURRED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>VISUAL IMPAIRMENT</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>VITREOUS FLOATERS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL DISCOMFORT</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>ABDOMINAL DISTENSION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>ABDOMINAL PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E4" events="3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>ANAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>ANGULAR CHEILITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>ASCITES</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>CHEILITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="19"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="20"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>DIAPHRAGMATIC HERNIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="20"/>
                <counts group_id="E2" events="15" subjects_affected="11" subjects_at_risk="19"/>
                <counts group_id="E3" events="13" subjects_affected="9" subjects_at_risk="17"/>
                <counts group_id="E4" events="16" subjects_affected="13" subjects_at_risk="20"/>
                <counts group_id="E5" events="6" subjects_affected="5" subjects_at_risk="7"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>DRY MOUTH</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>DYSPEPSIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="19"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>DYSPHAGIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>FLATULENCE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>GASTRIC ULCER</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>GASTRITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>GASTROOESOPHAGEAL REFLUX DISEASE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>GINGIVAL BLEEDING</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>GLOSSITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>GLOSSODYNIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>HAEMATEMESIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>HAEMATOCHEZIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>HAEMORRHOIDS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>LIP OEDEMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>LIP PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>LIP SWELLING</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>MOUTH ULCERATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>MUCOUS STOOLS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="20"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="17"/>
                <counts group_id="E4" events="8" subjects_affected="6" subjects_at_risk="20"/>
                <counts group_id="E5" events="5" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>OESOPHAGITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>ORAL DISCHARGE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>ORAL PAIN</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>RECTAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>STOMATITIS</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="19"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>TOOTHACHE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="20"/>
                <counts group_id="E2" events="8" subjects_affected="4" subjects_at_risk="19"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="20"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>ASTHENIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>CHEST PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>CHILLS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>FACE OEDEMA</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>FACIAL PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="20"/>
                <counts group_id="E2" events="14" subjects_affected="9" subjects_at_risk="19"/>
                <counts group_id="E3" events="7" subjects_affected="5" subjects_at_risk="17"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="20"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>GENERALISED OEDEMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>INFLUENZA LIKE ILLNESS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>LOCALISED OEDEMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>MALAISE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>MUCOSAL INFLAMMATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>OEDEMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>OEDEMA PERIPHERAL</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PAIN</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PERIPHERAL SWELLING</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PYREXIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="9" subjects_affected="7" subjects_at_risk="19"/>
                <counts group_id="E3" events="9" subjects_affected="5" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>SWELLING FACE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERSENSITIVITY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>BRONCHITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>CANDIDA INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>CELLULITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>CONJUNCTIVITIS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>CYSTITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>CYSTITIS BACTERIAL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>DEVICE RELATED INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>DIVERTICULITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>INFLUENZA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>LOWER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>NASOPHARYNGITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>ORAL CANDIDIASIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>ORAL HERPES</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>OTITIS EXTERNA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>OTITIS MEDIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>RASH PUSTULAR</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>RHINITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>SKIN INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>STAPHYLOCOCCAL INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>TONGUE FUNGAL INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>TOOTH INFECTION</sub_title>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="19"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION STAPHYLOCOCCAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>VIRAL INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>CONTUSION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>FACE INJURY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>FALL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>INFUSION RELATED REACTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>INJURY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>LIMB INJURY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>POST PROCEDURAL SWELLING</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>SKIN LACERATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>STRESS FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>WOUND COMPLICATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>ALANINE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>ASPARTATE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="4" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>BLOOD ALKALINE PHOSPHATASE INCREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>BLOOD BILIRUBIN INCREASED</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>BLOOD CREATINE PHOSPHOKINASE INCREASED</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="20"/>
                <counts group_id="E2" events="9" subjects_affected="7" subjects_at_risk="19"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>BLOOD CREATININE INCREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>BLOOD MAGNESIUM DECREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>BLOOD POTASSIUM DECREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>BLOOD PRESSURE DECREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>BLOOD PRESSURE INCREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>BLOOD THYROID STIMULATING HORMONE INCREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>BLOOD URIC ACID INCREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>BRAIN NATRIURETIC PEPTIDE INCREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>C-REACTIVE PROTEIN INCREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>CYTOMEGALOVIRUS TEST POSITIVE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>EJECTION FRACTION DECREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>GAMMA-GLUTAMYLTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>HAEMOGLOBIN DECREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>INTERNATIONAL NORMALISED RATIO INCREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PLATELET COUNT DECREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PLATELET COUNT INCREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>VITAMIN B12 DECREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>VITAMIN D DECREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>WEIGHT DECREASED</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>CACHEXIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>DECREASED APPETITE</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="20"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="19"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>DEHYDRATION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>HYPERCALCAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>HYPERGLYCAEMIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>HYPERKALAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>HYPOALBUMINAEMIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>HYPOCALCAEMIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>HYPOKALAEMIA</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>HYPOMAGNESAEMIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>HYPONATRAEMIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>HYPOPHOSPHATAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>IRON DEFICIENCY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ARTHRALGIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>BACK PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>BONE PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>FLANK PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>GROIN PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>JOINT SWELLING</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>MUSCLE SPASMS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>MUSCULAR WEAKNESS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>MUSCULOSKELETAL CHEST PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>MUSCULOSKELETAL PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>MYALGIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>MYOSITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>NECK PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>OSTEONECROSIS OF JAW</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PAIN IN EXTREMITY</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>SYNOVITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>TRISMUS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>ADENOCARCINOMA OF COLON</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>CANCER PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>KERATOACANTHOMA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>TUMOUR HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>APHASIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>CAUDA EQUINA SYNDROME</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>CEREBRAL INFARCTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="19"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>DIZZINESS POSTURAL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>DYSARTHRIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>DYSGEUSIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>LETHARGY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>LUMBAR RADICULOPATHY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>NEUROPATHY PERIPHERAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PARAESTHESIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PRESYNCOPE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>RESTLESS LEGS SYNDROME</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>SCIATICA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>STATUS EPILEPTICUS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>SYNCOPE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>TASTE DISORDER</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>ANGER</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>ANXIETY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>CONFUSIONAL STATE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>DEPRESSION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>DISORIENTATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>INSOMNIA</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE KIDNEY INJURY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>DYSURIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>HAEMATURIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>NOCTURIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>POLLAKIURIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PROTEINURIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>RENAL FAILURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>RENAL IMPAIRMENT</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>URINARY RETENTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>URINARY TRACT OBSTRUCTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>URINARY TRACT PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>SCROTAL OEDEMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>TESTICULAR SWELLING</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>VAGINAL DISCHARGE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>VAGINAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>COUGH</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="19"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>DYSPHONIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>DYSPNOEA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>DYSPNOEA EXERTIONAL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>EPISTAXIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>HAEMOPTYSIS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>LARYNGEAL OEDEMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>NASAL CONGESTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>NASAL OBSTRUCTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>OROPHARYNGEAL PAIN</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PNEUMONITIS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PRODUCTIVE COUGH</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>RALES</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>WHEEZING</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ALOPECIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>BLISTER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>DERMATITIS</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>DERMATITIS ACNEIFORM</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="20"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>DERMATITIS PSORIASIFORM</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>DRY SKIN</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="20"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>ECZEMA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>ERYTHEMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>INTERTRIGO</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>NIGHT SWEATS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>ONYCHOCLASIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PRURITUS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="20"/>
                <counts group_id="E5" events="6" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>RASH</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="20"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="19"/>
                <counts group_id="E3" events="14" subjects_affected="12" subjects_at_risk="17"/>
                <counts group_id="E4" events="6" subjects_affected="5" subjects_at_risk="20"/>
                <counts group_id="E5" events="7" subjects_affected="5" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>RASH ERYTHEMATOUS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>RASH MACULO-PAPULAR</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>RASH PAPULAR</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>RASH PRURITIC</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>SKIN FISSURES</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>STASIS DERMATITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>URTICARIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>FLUSHING</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>HYPERTENSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="8" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>HYPOTENSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>LYMPHOEDEMA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>ORTHOSTATIC HYPOTENSION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Communications</name_or_title>
      <organization>Hoffmann-La Roche</organization>
      <phone>800 821-8590</phone>
      <email>genentech@druginfo.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/NCT03264066
org study id: WO39760
secondary id: 2017-000794-37
nct id: NCT03264066
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a study to evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus
      atezolizumab in participants with advanced solid tumors including the following cohorts:
      squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma (UC), and renal
      cell carcinoma (RCC).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate (ORR)
time frame: Up to approximately 31 months
description: Objective response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive tumor assessments ≥4 weeks apart, as determined by the investigators using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions.
measure: Overall Survival (OS)
time frame: Up to approximately 31 months
description: Overall survival was defined as the time from enrollment to death from any cause. The median for OS is Kaplan-Meier estimate. 95% CI for median was computed using the method of Brookmeyer and Crowley.
measure: Progression-Free Survival (PFS)
time frame: Up to approximately 31 months
description: PFS was defined as the time from enrollment to the first occurrence of disease progression as determined by the investigator(s), using RECIST v1.1, or to death from any cause, whichever occurs first. Disease progression was defined as ≥20% increase in in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions.
measure: Duration of Response (DOR)
time frame: Up to approximately 22 months
description: DOR was defined as the time from the first occurrence of a documented, confirmed objective response to disease progression as determined by the investigator, using RECIST v1.1, or to death from any cause, whichever occurs first. Objective response was defined as a complete response (CR) or a partial response (PR) on two consecutive tumor assessments ≥4 weeks apart. CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions. Disease progression was defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions. Presented here is median DOR at the time of primary analysis. The median for the duration of response is Kaplan-Meier estimate. 95% CI for median was computed using the method of Brookmeyer and Crowley.
measure: Disease Control Rate (DCR)
time frame: At 16 weeks
description: DCR was defined as the percentage of participants with a complete response (CR), a partial response (PR), or stable disease at 16 weeks as determined by the investigator using RECIST v1.1. CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions. Stable disease was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for disease progression. Disease progression was defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions.
measure: Number of Participants With Adverse Events
time frame: Up to approximately 31 months
description: An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
measure: Maximum Plasma Concentration (Cmax) of Cobimetinib
time frame: Day 15 of Cycle 3 (cycle is 28 days): 2-4 hours after cobimetinib dose
description: Cmax is the maximum (or peak) concentration that a study drug achieves in the body.
measure: Minimum Plasma Concentration (Cmin) of Cobimetinib
time frame: Day 15 of Cycle 3 (cycle is 28 days): prior to cobimetinib dose
description: Cmin is the minimum (or trough) concentration that a study drug achieves in the body.
measure: Maximum Serum Concentration (Cmax) of Atezolizumab
time frame: 30 minutes following end of atezolizumab infusion on Day 15 of Cycle 3 (each cycle is 28 days)
description: Cmax is the maximum (or peak) concentration that a study drug achieves in the body.
measure: Minimum Serum Concentration (Cmin) of Atezolizumab
time frame: Prior to atezolizumab infusion on Day 1 of Cycles (each cycle is 28 days) 2, 4, 8, 12, and 16, Day 15 of Cycle 3
description: Cmin is the minimum (or trough) concentration that a study drug achieves in the body.
measure: Number of Participants With Anti-drug Antibodies (ADAs)
time frame: Day 1 of Cycles (each cycle is 28 days) 1, 2, 4, 8, 12, and 16; Day 15 of Cycle 3; at atezolizumab treatment discontinuation visit, and <90 days after last atezolizumab infusion (up to approximately 31 months)
description: Participants were considered to be ADA positive if they were missing data at baseline but developed an ADA response following study drug administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 4-fold greater (i.e., ≥0.60-titer units) than the titer of the baseline sample (treatment-enhanced ADA response). Participants were considered to be ADA negative if they were missing data at baseline, had a post-baseline ADA result, and all post-baseline samples were negative, or if they were ADA positive at baseline but did not have any post-baseline samples with a titer that was at least 4-fold greater than the titer of the baseline sample (treatment unaffected).
arm group label: Cohort 1 - SCCHN - Treatment Naive
arm group type: Experimental
description: In participants with recurrent or advanced / metastatic SSCHN who are anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
arm group label: Cohort 2 - UC - Treatment Naive
arm group type: Experimental
description: In participants with advanced / metastatic UC who are anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
arm group label: Cohort 3 - RCC - Treatment Naive
arm group type: Experimental
description: In participants with metastatic RCC who are anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib will be administered at the approved dose and schedule of 60 milligrams (mg) once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
arm group label: Cohort 4 - SCCHN - Previous Treatment Exposure
arm group type: Experimental
description: In participants with SCCHN whose disease has progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
arm group label: Cohort 5 - UC - Previous Treatment Exposure
arm group type: Experimental
description: In participants with UC whose disease has progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
arm group label: Cohort 6 - RCC - Previous Treatment Exposure
arm group type: Experimental
description: In participants with RCC whose disease has progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
arm group label: Cohort 7 - Biopsy Cohort
arm group type: Experimental
description: In participants with solid non-melanoma, non- hematologic tumors who previously developed primary or secondary resistance to an anti-PD-1 or anti-PD-L1 agent, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle. The first dose of atezolizumab of 840 mg by IV infusions on Day 15 of Cycle 1. Thereafter, they will receive atezolizumab 840 mg IV infusion Q2W on Days 1 and 15 of Cycle 2 and all subsequent cycles.
intervention type: Drug
intervention name: Cobimetinib
description: Participants will receive cobimetinib 60 mg (3 tablets of 20 mg each) orally once a day on Days 1-21 of each 28-day cycle.
arm group label: Cohort 1 - SCCHN - Treatment Naive
arm group label: Cohort 2 - UC - Treatment Naive
arm group label: Cohort 3 - RCC - Treatment Naive
arm group label: Cohort 4 - SCCHN - Previous Treatment Exposure
arm group label: Cohort 5 - UC - Previous Treatment Exposure
arm group label: Cohort 6 - RCC - Previous Treatment Exposure
arm group label: Cohort 7 - Biopsy Cohort
other name: Cotellic
intervention type: Drug
intervention name: Atezolizumab
description: Atezolizumab will be given at a fixed dose of 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
arm group label: Cohort 1 - SCCHN - Treatment Naive
arm group label: Cohort 2 - UC - Treatment Naive
arm group label: Cohort 3 - RCC - Treatment Naive
arm group label: Cohort 4 - SCCHN - Previous Treatment Exposure
arm group label: Cohort 5 - UC - Previous Treatment Exposure
arm group label: Cohort 6 - RCC - Previous Treatment Exposure
other name: Tecentriq
intervention type: Drug
intervention name: Atezolizumab Cohort 7
description: Only for participants in cohort 7, the first dose of atezolizumab of 840 mg will be given by IV infusion on Day 15 of Cycle 1; thereafter, they will receive atezolizumab 840 mg IV infusion Q2W on Days 1 and 15 of Cycle 2 and all subsequent cycles.
arm group label: Cohort 7 - Biopsy Cohort
other name: Tecentriq
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
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facility: 
facility: 
facility: 
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country: Belgium
country: Germany
country: Hungary
country: Korea, Republic of
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Atezolizumab
mesh term: Antibodies, Monoclonal
provided document: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 