<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/NCT03780010</url>
  </required_header>
  <id_info>
    <org_study_id>105LC101</org_study_id>
    <nct_id>NCT03780010</nct_id>
  </id_info>
  <brief_title>Study of TRC105 + Paclitaxel/Carboplatin and Bevacizumab in Patients With NSCLC</brief_title>
  <official_title>A Phase 1b Dose-escalation Study of TRC105 in Combination With Paclitaxel/Carboplatin and Bevacizumab in Patients With Stage 4 Non-Squamous Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tracon Pharmaceuticals Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tracon Pharmaceuticals Inc.</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 single center, open-label, nonrandomized, phase 1b, dose-finding study of TRC105 in&#xD;
      combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive&#xD;
      patients with stage IV non-squamous NSCLC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bevacizumab is a monoclonal antibody to vascular endothelial growth factor (VEGF) that&#xD;
      inhibits angiogenesis and extends survival in non-squamous non-small cell lung cancer (NSCLC)&#xD;
      patients when given with carboplatin and paclitaxel. TRC105 is an antibody to endoglin, an&#xD;
      essential angiogenic target expressed on proliferating endothelial cells that is distinct&#xD;
      from the VEGFR and overexpressed in response to VEGF inhibition. TRC105 inhibits&#xD;
      angiogenesis, tumor growth and metastases in preclinical models and complements the activity&#xD;
      of antibodies and small molecules that target the VEGFR. In a phase 1b study, the combination&#xD;
      of TRC105 and bevacizumab produced radiographic reductions in tumor volume in&#xD;
      bevacizumab-refractory patients, and was well tolerated. TRC105 was also well tolerated with&#xD;
      chemotherapy in a trial with capecitabine in breast cancer patients. The use of TRC105 with&#xD;
      bevacizumab and paclitaxel/carboplatin may result in more effective angiogenesis inhibition&#xD;
      and improved clinical efficacy over that seen with bevacizumab and paclitaxel/carboplatin&#xD;
      alone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2015</start_date>
  <completion_date type="Actual">June 2019</completion_date>
  <primary_completion_date type="Actual">June 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment-Emergent Adverse Events</measure>
    <time_frame>from screening until completion of follow-up, on average 6 months</time_frame>
    <description>Incidence of treatment-emergent (i.e. TRC105, bevacizumab, paclitaxel and/or carboplatin) adverse events by CTCAE v4.03</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall RECIST 1.1 Response Rate</measure>
    <time_frame>6 months</time_frame>
    <description>Response rate determined according to RECIST 1.1 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Patients With Progression-free Survival (PFS) at 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>Number of patients with progression-free survival at 6 months determined according to RECIST 1.1 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Progression Free Survival</measure>
    <time_frame>months</time_frame>
    <description>Median duration of progression free survival according to RECIST 1.1 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Profile of TRC105 When Given With Bevacizumab and Paclitaxel/Carboplatin</measure>
    <time_frame>3 months</time_frame>
    <description>Trough serum TRC105 pharmacokinetic concentrations at steady state (cycle 3 day 1) will be measured using validated ELISA methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Who Have TRC105 Positive Anti-Product Antibodies</measure>
    <time_frame>6 months</time_frame>
    <description>Anti-product antibody concentrations will be measured using validated ELISA methods. Anti-product antibody concentrations will be evaluated in the context of pharmacokinetic parameters and AE profiles.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Non Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>TRC105 + B + P + C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TRC105</intervention_name>
    <description>Dose-finding study of TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC.</description>
    <arm_group_label>TRC105 + B + P + C</arm_group_label>
    <other_name>Bevacizumab</other_name>
    <other_name>Paclitaxel</other_name>
    <other_name>Carboplatin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Stage 4 Non-Squamous Cell Lung Cancer that has not been treated previously with&#xD;
             systemic chemotherapy or bevacizumab, but may have received prior targeted treatment&#xD;
             (e.g., alk1 inhibitor)&#xD;
&#xD;
          -  ECOG performance status ≤ 1&#xD;
&#xD;
          -  Measurable disease by RECIST&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Non-small cell lung cancer of squamous histology&#xD;
&#xD;
          -  Current treatment on another therapeutic clinical trial&#xD;
&#xD;
          -  Patients who have received wide field radiotherapy ≤ 28 days (defined as &gt; 50% of&#xD;
             volume of pelvic bones or equivalent) or limited field radiation for palliation &lt; 14&#xD;
             days prior to study registration or those patients who have not recovered adequately&#xD;
             from side effects of such therapy&#xD;
&#xD;
          -  Active bleeding or pathologic condition that carries a high risk of bleeding (e.g.&#xD;
             hereditary hemorrhagic telangiectasia). Patients who have been uneventfully&#xD;
             anti-coagulated with low molecular weight heparin are eligible.&#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>Charles Theuer, MD</last_name>
    <role>Study Director</role>
    <affiliation>TRACON Pharmaceuticals</affiliation>
  </overall_official>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <results_first_submitted>August 8, 2019</results_first_submitted>
  <results_first_submitted_qc>October 4, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 28, 2019</results_first_posted>
  <last_update_submitted>October 4, 2019</last_update_submitted>
  <last_update_submitted_qc>October 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2019</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>Lung Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Carboplatin</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>July 7, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT03780010/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>medical clinic</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin</title>
          <description>Dose Level 1: 8 mg/kg TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC</description>
        </group>
        <group group_id="P2">
          <title>10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin</title>
          <description>Dose Level 2: 10 mg/kg TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin</title>
          <description>Dose Level 1: 8 mg/kg of TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC.</description>
        </group>
        <group group_id="B2">
          <title>10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin</title>
          <description>Dose Level 2: 10 mg/kg of TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="3"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="15"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69" lower_limit="56" upper_limit="75"/>
                    <measurement group_id="B2" value="70" lower_limit="45" upper_limit="82"/>
                    <measurement group_id="B3" value="69" lower_limit="45" upper_limit="82"/>
                  </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="6"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="7"/>
                  </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_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="12"/>
                  </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_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of prior regimens</title>
          <units>number of prior regimens</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="B2" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="B3" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Treatment-Emergent Adverse Events</title>
        <description>Incidence of treatment-emergent (i.e. TRC105, bevacizumab, paclitaxel and/or carboplatin) adverse events by CTCAE v4.03</description>
        <time_frame>from screening until completion of follow-up, on average 6 months</time_frame>
        <population>All patients who received at least a portion of a dose of any study drug (TRC105, Bevacizumab or Paclitaxel/Carboplatin)</population>
        <group_list>
          <group group_id="O1">
            <title>8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin</title>
            <description>Dose level 1: 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin</description>
          </group>
          <group group_id="O2">
            <title>10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin</title>
            <description>Dose level 2: 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment-Emergent Adverse Events</title>
          <description>Incidence of treatment-emergent (i.e. TRC105, bevacizumab, paclitaxel and/or carboplatin) adverse events by CTCAE v4.03</description>
          <population>All patients who received at least a portion of a dose of any study drug (TRC105, Bevacizumab or Paclitaxel/Carboplatin)</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="3"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants who experienced an AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants who experienced a TRC105 related AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants who experienced a Bev related AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants who experienced a Carbo related AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants who experienced a Pac related AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall RECIST 1.1 Response Rate</title>
        <description>Response rate determined according to RECIST 1.1 criteria</description>
        <time_frame>6 months</time_frame>
        <population>Number of patients with a baseline scan and at least 1 on study scan were evaluable for response rate determination</population>
        <group_list>
          <group group_id="O1">
            <title>8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin</title>
            <description>Dose level 1: 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin</description>
          </group>
          <group group_id="O2">
            <title>10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin</title>
            <description>Dose level 2: 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin</description>
          </group>
        </group_list>
        <measure>
          <title>Overall RECIST 1.1 Response Rate</title>
          <description>Response rate determined according to RECIST 1.1 criteria</description>
          <population>Number of patients with a baseline scan and at least 1 on study scan were evaluable for response rate determination</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="3"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Stable Disease Best Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Partial Response Best Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Progressive Disease Best Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Complete Response Best Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Patients With Progression-free Survival (PFS) at 6 Months</title>
        <description>Number of patients with progression-free survival at 6 months determined according to RECIST 1.1 criteria</description>
        <time_frame>6 months</time_frame>
        <population>Number of patients progression free according to RECIST 1.1 after 6 months of treatment</population>
        <group_list>
          <group group_id="O1">
            <title>8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin</title>
            <description>Dose level 1: 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin</description>
          </group>
          <group group_id="O2">
            <title>10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin</title>
            <description>Dose level 2: 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Patients With Progression-free Survival (PFS) at 6 Months</title>
          <description>Number of patients with progression-free survival at 6 months determined according to RECIST 1.1 criteria</description>
          <population>Number of patients progression free according to RECIST 1.1 after 6 months of treatment</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="3"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Progression Free Survival</title>
        <description>Median duration of progression free survival according to RECIST 1.1 criteria</description>
        <time_frame>months</time_frame>
        <population>Number of patients progression free according to RECIST 1.1 after 6 months of treatment</population>
        <group_list>
          <group group_id="O1">
            <title>8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin</title>
            <description>Dose level 110 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin</description>
          </group>
          <group group_id="O2">
            <title>10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin</title>
            <description>Dose level 2: 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin</description>
          </group>
        </group_list>
        <measure>
          <title>Median Progression Free Survival</title>
          <description>Median duration of progression free survival according to RECIST 1.1 criteria</description>
          <population>Number of patients progression free according to RECIST 1.1 after 6 months of treatment</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" spread="1.73"/>
                    <measurement group_id="O2" value="6.5" spread="3.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetic Profile of TRC105 When Given With Bevacizumab and Paclitaxel/Carboplatin</title>
        <description>Trough serum TRC105 pharmacokinetic concentrations at steady state (cycle 3 day 1) will be measured using validated ELISA methods.</description>
        <time_frame>3 months</time_frame>
        <population>All patients who received at least a portion of a dose of TRC105 with PK samples collected at baseline and at least 1 time point on study</population>
        <group_list>
          <group group_id="O1">
            <title>8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin</title>
            <description>Dose level 1: 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin</description>
          </group>
          <group group_id="O2">
            <title>10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin</title>
            <description>Dose level 2: 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Profile of TRC105 When Given With Bevacizumab and Paclitaxel/Carboplatin</title>
          <description>Trough serum TRC105 pharmacokinetic concentrations at steady state (cycle 3 day 1) will be measured using validated ELISA methods.</description>
          <population>All patients who received at least a portion of a dose of TRC105 with PK samples collected at baseline and at least 1 time point on study</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56600" lower_limit="52000" upper_limit="65800"/>
                    <measurement group_id="O2" value="103228" lower_limit="3780" upper_limit="211000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Who Have TRC105 Positive Anti-Product Antibodies</title>
        <description>Anti-product antibody concentrations will be measured using validated ELISA methods. Anti-product antibody concentrations will be evaluated in the context of pharmacokinetic parameters and AE profiles.</description>
        <time_frame>6 months</time_frame>
        <population>All patients who received at least a portion of a dose of TRC105 with immunogenicity samples collected at baseline and at least 1 time point on study</population>
        <group_list>
          <group group_id="O1">
            <title>8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin</title>
            <description>Dose level 1: 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin</description>
          </group>
          <group group_id="O2">
            <title>10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin</title>
            <description>Dose level 2: 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Who Have TRC105 Positive Anti-Product Antibodies</title>
          <description>Anti-product antibody concentrations will be measured using validated ELISA methods. Anti-product antibody concentrations will be evaluated in the context of pharmacokinetic parameters and AE profiles.</description>
          <population>All patients who received at least a portion of a dose of TRC105 with immunogenicity samples collected at baseline and at least 1 time point on study</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="3"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Ptn with low titer treatment emergent ADA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ptn without treatment emergent ADA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From screening until completion of follow-up, on average 6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>TRC105 (0.00-0.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin</title>
          <description>Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 0.00-0.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.</description>
        </group>
        <group group_id="E2">
          <title>TRC105 (1.00-1.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin</title>
          <description>Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 1.00-1.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.</description>
        </group>
        <group group_id="E3">
          <title>TRC105 (2.00-2.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin</title>
          <description>Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 2.00-2.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.</description>
        </group>
        <group group_id="E4">
          <title>TRC105 (3.0-3.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin</title>
          <description>Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 3.00-3.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.</description>
        </group>
        <group group_id="E5">
          <title>TRC105 (4.0-4.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin</title>
          <description>Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 4.00-4.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.</description>
        </group>
        <group group_id="E6">
          <title>TRC105 (5.0-5.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin</title>
          <description>Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 5.00-5.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.</description>
        </group>
        <group group_id="E7">
          <title>TRC105 (6.00-6.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin</title>
          <description>Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 6.00-6.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.</description>
        </group>
        <group group_id="E8">
          <title>TRC105 (7.00-7.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin</title>
          <description>Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 7.0-7.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.</description>
        </group>
        <group group_id="E9">
          <title>TRC105 (8.00-8.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin</title>
          <description>Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 8.0-8.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.</description>
        </group>
        <group group_id="E10">
          <title>TRC105 (9.00-9.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin</title>
          <description>Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 9.0-9.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.</description>
        </group>
        <group group_id="E11">
          <title>TRC105 (10.00 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin</title>
          <description>Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 at a dosage of 10.00 mg/kg at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (14.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hematemesis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non Cardiac Chest Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Left arm wound infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Febrile Neutropenic Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Left forearm wound/degloving injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertensive Encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Altered Mental Status</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoxemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (14.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="5"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="5"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="5" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="13" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E7" events="5" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="4" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="2" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="3" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="3" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </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="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Intermittent atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Intermittent tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Left Ventricular Dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Occasional Palpitations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Earache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Dry Eyes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Eye floaters</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Visual Disturbance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Cramps</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Abdominal Discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Anal hemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Belching</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Bleeding gums</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Bleeding hemorrhoids</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="3" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Constipation intermittent</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="9" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E7" events="3" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="10" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E10" events="2" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Diarrhea, Intermittent</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dry Mouth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Emesis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Gingival Bleeding</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Gingival Ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Gum Bleeding</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Heartburn</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hematemesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hemorrhoids</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Intermittent Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Intermittent left lower quadrant abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Intermittent Diarrhea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Intermittent Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Loose bowel movement</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Mouth pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Mouth Soreness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="7" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="4" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Oral Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E8" events="4" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Periodontal Disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Rectal Bleeding</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>RUQ Tenderness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sore mouth</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="4" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E10" events="2" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Tooth loss</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Tooth pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Ulceration, right corner of mouth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Worsening GERD</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Ankle edema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Bilateral Ankle edema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Central chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Chest Pain non cardiac</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cold intolerance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E5" events="6" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E6" events="15" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E7" events="8" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E8" events="13" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E9" events="31" subjects_affected="5" subjects_at_risk="5"/>
                <counts group_id="E10" events="11" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Flu like symptoms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Generalized weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>IV infiltration during pre-med Emend administration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Left hand edema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Lower Extremity Edema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Musositis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="5" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="3" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="5" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Non cardiac chest pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pain, right posterior chest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pedal Edema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Perineal cyst rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pleurex catheter site irritation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Right ankle edema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Right chest discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Swelling/fullness to left supraclavicular area</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Wound dehiscence port area</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergy symptoms, sneezing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bladder infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Clostridium Difficile Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cold Sores</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cold Symptoms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Facial Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Gingival abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Mucosal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Respiratory cold symptoms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Skin infection from perianal cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Skin infection left lower leg</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Upper respiratory infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Wound infection port area</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Abrasions arms and face</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Infusion Reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Left forearm wound</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pathological pelvic fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Upper arm lacerations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Decreased Platelet Count</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Elevated TSH</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Weight loss</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="3" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="3" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E8" events="4" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E9" events="6" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="2" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypernatremia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypomagnesemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Loss of appetite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </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="8" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" events="12" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="5" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E9" events="7" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Arthralgia Knees</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Arthralgias</sub_title>
                <counts group_id="E1" events="7" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="12" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cramps Extremities</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hip pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Jaw Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Left Ankle Swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Left arm pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Left lower leg pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Left shoulder pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Leg Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Leg weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="5" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E9" events="6" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neck Spasms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pain arm, leg, back</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pain, back</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pain beneath right shoulder blade</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pain, bilateral legs</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pain, L hip</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pain, right hand</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pain, neck</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Right flank pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Right knee pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Right shoulder pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Swelling, ankles</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dizziness upon rising</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="3" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="7" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Facial Numbness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hand tremors</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" events="4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" events="5" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E8" events="22" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="14" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E10" events="3" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E11" events="2" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Intermittent headaches</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Memory impairment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neuropathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="4" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E6" events="6" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="8" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E9" events="5" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neuropathy, fingers</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neuropathy, feet</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="5" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="3" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="3" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="2" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Restless leg</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Right hand tremors</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Short term memory loss</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sleepiness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Taste disturbances</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Temporal headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Auditory Hallucinations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Confusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </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="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Leukocyturia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Patchy perfusion of the kidneys</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Right pelvic pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="3" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vaginal Bleeding</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vaginal Tenderness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Allergic Rhinitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood in sputum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood with sinus drainage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Chest Congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>COPD Exacerbation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="5" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="4" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" events="5" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="9" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E7" events="5" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E8" events="3" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E9" events="8" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Erythematous Rash, both hands</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hemoptysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hoarseness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypoxemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypoxemic Respiratory Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Increased Phlegm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Intermittent Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Intermittent shortness of breath</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Nasal Congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Nose bleed</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Nose pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pleural Effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="3" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Shortness of breath</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="3" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E8" events="5" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E9" events="8" subjects_affected="4" subjects_at_risk="5"/>
                <counts group_id="E10" events="5" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E11" events="2" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sinus Congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sinus Drainage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sinus Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sore throat</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="7" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Throat pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acneform rash, scalp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Acneiform rash, face</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dry Skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dry Skin, Face</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dry, hyperpigmented skin - posterior neck</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Erythema, palms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hair Loss</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Macropopular rash, bilateral arms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="3" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E9" events="5" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Redness, right hand</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Redness, groin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Skin Ulceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Swelling right eyebrow area</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Telangiectasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E8" events="5" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E9" events="8" subjects_affected="4" subjects_at_risk="5"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Warty scalp lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Intermittent Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Phlebitis, left arm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Phlebitis, right arm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Thromboembolic event (DVT)</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Monitor</name_or_title>
      <organization>TRACON Pharmaceuticals Inc</organization>
      <phone>8585500780</phone>
      <email>clinicaltrials@traconpharma.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/NCT03780010
org study id: 105LC101
nct id: NCT03780010
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a single center, open-label, nonrandomized, phase 1b, dose-finding study of TRC105 in
      combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive
      patients with stage IV non-squamous NSCLC.
Bevacizumab is a monoclonal antibody to vascular endothelial growth factor (VEGF) that
      inhibits angiogenesis and extends survival in non-squamous non-small cell lung cancer (NSCLC)
      patients when given with carboplatin and paclitaxel. TRC105 is an antibody to endoglin, an
      essential angiogenic target expressed on proliferating endothelial cells that is distinct
      from the VEGFR and overexpressed in response to VEGF inhibition. TRC105 inhibits
      angiogenesis, tumor growth and metastases in preclinical models and complements the activity
      of antibodies and small molecules that target the VEGFR. In a phase 1b study, the combination
      of TRC105 and bevacizumab produced radiographic reductions in tumor volume in
      bevacizumab-refractory patients, and was well tolerated. TRC105 was also well tolerated with
      chemotherapy in a trial with capecitabine in breast cancer patients. The use of TRC105 with
      bevacizumab and paclitaxel/carboplatin may result in more effective angiogenesis inhibition
      and improved clinical efficacy over that seen with bevacizumab and paclitaxel/carboplatin
      alone.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Treatment-Emergent Adverse Events
time frame: from screening until completion of follow-up, on average 6 months
description: Incidence of treatment-emergent (i.e. TRC105, bevacizumab, paclitaxel and/or carboplatin) adverse events by CTCAE v4.03
measure: Overall RECIST 1.1 Response Rate
time frame: 6 months
description: Response rate determined according to RECIST 1.1 criteria
measure: Percent of Patients With Progression-free Survival (PFS) at 6 Months
time frame: 6 months
description: Number of patients with progression-free survival at 6 months determined according to RECIST 1.1 criteria
measure: Median Progression Free Survival
time frame: months
description: Median duration of progression free survival according to RECIST 1.1 criteria
measure: Pharmacokinetic Profile of TRC105 When Given With Bevacizumab and Paclitaxel/Carboplatin
time frame: 3 months
description: Trough serum TRC105 pharmacokinetic concentrations at steady state (cycle 3 day 1) will be measured using validated ELISA methods.
measure: Number of Patients Who Have TRC105 Positive Anti-Product Antibodies
time frame: 6 months
description: Anti-product antibody concentrations will be measured using validated ELISA methods. Anti-product antibody concentrations will be evaluated in the context of pharmacokinetic parameters and AE profiles.
arm group label: TRC105 + B + P + C
arm group type: Experimental
description: TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC.
intervention type: Drug
intervention name: TRC105
description: Dose-finding study of TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC.
arm group label: TRC105 + B + P + C
other name: Bevacizumab
other name: Paclitaxel
other name: Carboplatin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Charles Theuer, MD
role: Study Director
affiliation: TRACON Pharmaceuticals
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Paclitaxel
mesh term: Carboplatin
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 