<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/NCT01716234</url>
  </required_header>
  <id_info>
    <org_study_id>P03579</org_study_id>
    <secondary_id>2007-004645-15</secondary_id>
    <secondary_id>MK-5592-032</secondary_id>
    <nct_id>NCT01716234</nct_id>
  </id_info>
  <brief_title>A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579)</brief_title>
  <official_title>Phase 1B Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children With Neutropenia (P03579)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this dose-escalation study is to evaluate the pharmacokinetics, safety, and&#xD;
      tolerability of oral posaconazole in immunocompromised children with neutropenia or expected&#xD;
      neutropenia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study was terminated early (10 July 2015) based on preliminary analysis of pharmacokinetic&#xD;
    data.&#xD;
  </why_stopped>
  <start_date type="Actual">April 17, 2008</start_date>
  <completion_date type="Actual">April 1, 2015</completion_date>
  <primary_completion_date type="Actual">April 1, 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)</measure>
    <time_frame>Up to 12 hours after the first dose (BID dose groups) or up to 8 hours after the first dose (TID dose (TID dose groups)</time_frame>
    <description>Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 1. The 12-hour sample was not obtained for the TID dose groups. Day 1 pharmacokinetic samples were not collected for participants 3 months to &lt;2 years of age weighing &lt;6.5 kg.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average Concentration of Posaconazole (Cavg) on Day 7 (Steady State)</measure>
    <time_frame>Up to 12 hours after the first dose on Day 7 (BID dose groups) or up to 8 hours after the first dose on Day 7 (TID dose</time_frame>
    <description>Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 7 (steady state). The 12-hour sample was not obtained for the TID dose groups. The target Cavg range was 500 to &lt;2500 ng/mL.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Adverse Event</measure>
    <time_frame>Up to Day 58</time_frame>
    <description>An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Adverse Event Leading to Study Drug Discontinuation</measure>
    <time_frame>Up to Day 28</time_frame>
    <description>An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">142</enrollment>
  <condition>Fungal Infections</condition>
  <arm_group>
    <arm_group_label>POS 12 BID 2 to &lt;7 Years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants aged 2 to &lt;7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>POS 12 BID 7 to &lt;18 Years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants aged 7 to &lt;18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>POS 18 BID 2 to &lt;7 Years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants aged 2 to &lt;7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>POS 18 BID 7 to &lt;18 Years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants aged 7 to &lt;18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>POS 18 TID 2 to &lt;7 Years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants aged 2 to &lt;7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>POS 18 TID 7 to &lt;18 Years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants aged 7 to &lt;18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>POS 12 TID 3 months to &lt;2 Years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants aged 3 months to &lt;2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Posaconazole 12 mg/kg/day BID</intervention_name>
    <description>Posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) (maximum 800 mg/day)</description>
    <arm_group_label>POS 12 BID 2 to &lt;7 Years</arm_group_label>
    <arm_group_label>POS 12 BID 7 to &lt;18 Years</arm_group_label>
    <other_name>SCH 056592</other_name>
    <other_name>MK-5592</other_name>
    <other_name>Noxafil®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Posaconazole 18 mg/kg/day BID</intervention_name>
    <description>Posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) (maximum 1200 mg/day)</description>
    <arm_group_label>POS 18 BID 2 to &lt;7 Years</arm_group_label>
    <arm_group_label>POS 18 BID 7 to &lt;18 Years</arm_group_label>
    <other_name>SCH 056592</other_name>
    <other_name>MK-5592</other_name>
    <other_name>Noxafil®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Posaconazole 18 mg/kg/day TID</intervention_name>
    <description>Posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) (maximum 1200 mg/day)</description>
    <arm_group_label>POS 18 TID 2 to &lt;7 Years</arm_group_label>
    <arm_group_label>POS 18 TID 7 to &lt;18 Years</arm_group_label>
    <other_name>SCH 056592</other_name>
    <other_name>MK-5592</other_name>
    <other_name>Noxafil®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Posaconazole 12 mg/kg/day TID</intervention_name>
    <description>Posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) (maximum 800 mg/day)</description>
    <arm_group_label>POS 12 TID 3 months to &lt;2 Years</arm_group_label>
    <other_name>SCH 056592</other_name>
    <other_name>MK-5592</other_name>
    <other_name>Noxafil®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documented or anticipated neutropenia expected to last at least 7 days and only in the&#xD;
             following clinical situations: acute leukemia; myelodysplasia; severe aplastic anemia;&#xD;
             autologous hematopoietic stem cell transplantation (HSCT) recipients; high risk&#xD;
             neuroblastoma; advanced stage non-Hodgkin's lymphoma; recipients of allogeneic HSCT&#xD;
             during the pre-engraftment (neutropenia) period&#xD;
&#xD;
          -  Participants of child-bearing potential must use a medically accepted method of&#xD;
&#xD;
        contraception throughout the study and for at least 30 days after stopping study&#xD;
        medication, unless they are surgically or medically sterile or agree to remain abstinent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Proven invasive fungal infection (IFI) before study entry&#xD;
&#xD;
          -  Severe nausea and/or vomiting at screening&#xD;
&#xD;
          -  Received posaconazole within 10 days before screening&#xD;
&#xD;
          -  Unable to receive study drug by mouth or via an intestinal (enteral) tube&#xD;
&#xD;
          -  Females who are pregnant, intend to become pregnant during the study, or are&#xD;
             breastfeeding&#xD;
&#xD;
          -  History of anaphylaxis attributed to the azole class of antifungal agents&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <removed_countries>
    <country>Canada</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Netherlands</country>
    <country>United States</country>
  </removed_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <results_first_submitted>March 15, 2016</results_first_submitted>
  <results_first_submitted_qc>March 15, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 15, 2016</results_first_posted>
  <last_update_submitted>July 27, 2018</last_update_submitted>
  <last_update_submitted_qc>July 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 27, 2018</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>Mycoses</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Posaconazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 160 participants were screened, 142 were randomized / enrolled, and 136 were treated. An arm planned for participants aged 3 months to &lt;2 years to receive posaconazole 18 mg/kg/day TID was never initiated.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>POS 12 BID 2 to &lt;7 Years</title>
          <description>Participants aged 2 to &lt;7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
        </group>
        <group group_id="P2">
          <title>POS 12 BID 7 to &lt;18 Years</title>
          <description>Participants aged 7 to &lt;18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
        </group>
        <group group_id="P3">
          <title>POS 18 BID 2 to &lt;7 Years</title>
          <description>Participants aged 2 to &lt;7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
        </group>
        <group group_id="P4">
          <title>POS 18 BID 7 to &lt;18 Years</title>
          <description>Participants aged 7 to &lt;18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
        </group>
        <group group_id="P5">
          <title>POS 18 TID 2 to &lt;7 Years</title>
          <description>Participants aged 2 to &lt;7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.</description>
        </group>
        <group group_id="P6">
          <title>POS 18 TID 7 to &lt;18 Years</title>
          <description>Participants aged 7 to &lt;18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.</description>
        </group>
        <group group_id="P7">
          <title>POS 12 TID 3 Months to &lt;2 Years</title>
          <description>Participants aged 3 months to &lt;2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="22"/>
                <participants group_id="P3" count="20"/>
                <participants group_id="P4" count="28"/>
                <participants group_id="P5" count="15"/>
                <participants group_id="P6" count="32"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="19"/>
                <participants group_id="P4" count="28"/>
                <participants group_id="P5" count="15"/>
                <participants group_id="P6" count="30"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="16"/>
                <participants group_id="P5" count="10"/>
                <participants group_id="P6" count="18"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="12"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="14"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did not meet protocol eligibility</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="4"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>POS 12 BID 2 to &lt;7 Years</title>
          <description>Participants aged 2 to &lt;7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
        </group>
        <group group_id="B2">
          <title>POS 12 BID 7 to &lt;18 Years</title>
          <description>Participants aged 7 to &lt;18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
        </group>
        <group group_id="B3">
          <title>POS 18 BID 2 to &lt;7 Years</title>
          <description>Participants aged 2 to &lt;7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
        </group>
        <group group_id="B4">
          <title>POS 18 BID 7 to &lt;18 Years</title>
          <description>Participants aged 7 to &lt;18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
        </group>
        <group group_id="B5">
          <title>POS 18 TID 2 to &lt;7 Years</title>
          <description>Participants aged 2 to &lt;7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.</description>
        </group>
        <group group_id="B6">
          <title>POS 18 TID 7 to &lt;18 Years</title>
          <description>Participants aged 7 to &lt;18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.</description>
        </group>
        <group group_id="B7">
          <title>POS 12 TID 3 Months to &lt;2 Years</title>
          <description>Participants aged 3 months to &lt;2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.</description>
        </group>
        <group group_id="B8">
          <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="24"/>
            <count group_id="B2" value="22"/>
            <count group_id="B3" value="20"/>
            <count group_id="B4" value="28"/>
            <count group_id="B5" value="15"/>
            <count group_id="B6" value="32"/>
            <count group_id="B7" value="1"/>
            <count group_id="B8" value="142"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.0" spread="1.3" lower_limit="2" upper_limit="7"/>
                    <measurement group_id="B2" value="11.9" spread="3.5" lower_limit="7" upper_limit="17"/>
                    <measurement group_id="B3" value="4.4" spread="1.5" lower_limit="2" upper_limit="7"/>
                    <measurement group_id="B4" value="12.2" spread="3.2" lower_limit="7" upper_limit="18"/>
                    <measurement group_id="B5" value="4.1" spread="1.3" lower_limit="3" upper_limit="7"/>
                    <measurement group_id="B6" value="13.1" spread="3.0" lower_limit="7" upper_limit="18"/>
                    <measurement group_id="B7" value="0.9" spread="0" lower_limit="1" upper_limit="1"/>
                    <measurement group_id="B8" value="8.9" spread="4.9" lower_limit="1" upper_limit="18"/>
                  </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="10"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="14"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="19"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="18"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)</title>
        <description>Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 1. The 12-hour sample was not obtained for the TID dose groups. Day 1 pharmacokinetic samples were not collected for participants 3 months to &lt;2 years of age weighing &lt;6.5 kg.</description>
        <time_frame>Up to 12 hours after the first dose (BID dose groups) or up to 8 hours after the first dose (TID dose (TID dose groups)</time_frame>
        <population>The pharmacokinetic evaluable population included all treated participants with evaluable samples applicable to the endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>POS 12 BID 2 to &lt;7 Years</title>
            <description>Participants aged 2 to &lt;7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
          </group>
          <group group_id="O2">
            <title>POS 12 BID 7 to &lt;18 Years</title>
            <description>Participants aged 7 to &lt;18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
          </group>
          <group group_id="O3">
            <title>POS 18 BID 2 to &lt;7 Years</title>
            <description>Participants aged 2 to &lt;7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
          </group>
          <group group_id="O4">
            <title>POS 18 BID 7 to &lt;18 Years</title>
            <description>Participants aged 7 to &lt;18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
          </group>
          <group group_id="O5">
            <title>POS 18 TID 2 to &lt;7 Years</title>
            <description>Participants aged 2 to &lt;7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.</description>
          </group>
          <group group_id="O6">
            <title>POS 18 TID 7 to &lt;18 Years</title>
            <description>Participants aged 7 to &lt;18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.</description>
          </group>
          <group group_id="O7">
            <title>POS 12 TID 3 Months to &lt;2 Years</title>
            <description>Participants aged 3 months to &lt;2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)</title>
          <description>Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 1. The 12-hour sample was not obtained for the TID dose groups. Day 1 pharmacokinetic samples were not collected for participants 3 months to &lt;2 years of age weighing &lt;6.5 kg.</description>
          <population>The pharmacokinetic evaluable population included all treated participants with evaluable samples applicable to the endpoint.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="5"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="122" spread="101"/>
                    <measurement group_id="O2" value="107" spread="92.5"/>
                    <measurement group_id="O3" value="112" spread="86.9"/>
                    <measurement group_id="O4" value="113" spread="100"/>
                    <measurement group_id="O5" value="68.4" spread="40.4"/>
                    <measurement group_id="O6" value="57.9" spread="30.2"/>
                    <measurement group_id="O7" value="68.5" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Average Concentration of Posaconazole (Cavg) on Day 7 (Steady State)</title>
        <description>Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 7 (steady state). The 12-hour sample was not obtained for the TID dose groups. The target Cavg range was 500 to &lt;2500 ng/mL.</description>
        <time_frame>Up to 12 hours after the first dose on Day 7 (BID dose groups) or up to 8 hours after the first dose on Day 7 (TID dose</time_frame>
        <population>The pharmacokinetic evaluable population included all treated participants with evaluable samples applicable to the endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>POS 12 BID 2 to &lt;7 Years</title>
            <description>Participants aged 2 to &lt;7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
          </group>
          <group group_id="O2">
            <title>POS 12 BID 7 to &lt;18 Years</title>
            <description>Participants aged 7 to &lt;18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
          </group>
          <group group_id="O3">
            <title>POS 18 BID 2 to &lt;7 Years</title>
            <description>Participants aged 2 to &lt;7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
          </group>
          <group group_id="O4">
            <title>POS 18 BID 7 to &lt;18 Years</title>
            <description>Participants aged 7 to &lt;18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
          </group>
          <group group_id="O5">
            <title>POS 18 TID 2 to &lt;7 Years</title>
            <description>Participants aged 2 to &lt;7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.</description>
          </group>
          <group group_id="O6">
            <title>POS 18 TID 7 to &lt;18 Years</title>
            <description>Participants aged 7 to &lt;18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.</description>
          </group>
          <group group_id="O7">
            <title>POS 12 TID 3 Months to &lt;2 Years</title>
            <description>Participants aged 3 months to &lt;2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Concentration of Posaconazole (Cavg) on Day 7 (Steady State)</title>
          <description>Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 7 (steady state). The 12-hour sample was not obtained for the TID dose groups. The target Cavg range was 500 to &lt;2500 ng/mL.</description>
          <population>The pharmacokinetic evaluable population included all treated participants with evaluable samples applicable to the endpoint.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="5"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="604" spread="779"/>
                    <measurement group_id="O2" value="1050" spread="789"/>
                    <measurement group_id="O3" value="485" spread="306"/>
                    <measurement group_id="O4" value="1240" spread="1400"/>
                    <measurement group_id="O5" value="620" spread="411"/>
                    <measurement group_id="O6" value="1150" spread="750"/>
                    <measurement group_id="O7" value="453" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Adverse Event</title>
        <description>An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.</description>
        <time_frame>Up to Day 58</time_frame>
        <population>The population analyzed was all treated participants.</population>
        <group_list>
          <group group_id="O1">
            <title>POS 12 BID 2 to &lt;7 Years</title>
            <description>Participants aged 2 to &lt;7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
          </group>
          <group group_id="O2">
            <title>POS 12 BID 7 to &lt;18 Years</title>
            <description>Participants aged 7 to &lt;18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
          </group>
          <group group_id="O3">
            <title>POS 18 BID 2 to &lt;7 Years</title>
            <description>Participants aged 2 to &lt;7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
          </group>
          <group group_id="O4">
            <title>POS 18 BID 7 to &lt;18 Years</title>
            <description>Participants aged 7 to &lt;18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
          </group>
          <group group_id="O5">
            <title>POS 18 TID 2 to &lt;7 Years</title>
            <description>Participants aged 2 to &lt;7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.</description>
          </group>
          <group group_id="O6">
            <title>POS 18 TID 7 to &lt;18 Years</title>
            <description>Participants aged 7 to &lt;18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.</description>
          </group>
          <group group_id="O7">
            <title>POS 12 TID 3 Months to &lt;2 Years</title>
            <description>Participants aged 3 months to &lt;2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Adverse Event</title>
          <description>An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.</description>
          <population>The population analyzed was all treated participants.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="19"/>
                <count group_id="O4" value="28"/>
                <count group_id="O5" value="15"/>
                <count group_id="O6" value="30"/>
                <count group_id="O7" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="16"/>
                    <measurement group_id="O4" value="26"/>
                    <measurement group_id="O5" value="13"/>
                    <measurement group_id="O6" value="30"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Adverse Event Leading to Study Drug Discontinuation</title>
        <description>An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.</description>
        <time_frame>Up to Day 28</time_frame>
        <population>The population analyzed was all treated participants.</population>
        <group_list>
          <group group_id="O1">
            <title>POS 12 BID 2 to &lt;7 Years</title>
            <description>Participants aged 2 to &lt;7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
          </group>
          <group group_id="O2">
            <title>POS 12 BID 7 to &lt;18 Years</title>
            <description>Participants aged 7 to &lt;18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
          </group>
          <group group_id="O3">
            <title>POS 18 BID 2 to &lt;7 Years</title>
            <description>Participants aged 2 to &lt;7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
          </group>
          <group group_id="O4">
            <title>POS 18 BID 7 to &lt;18 Years</title>
            <description>Participants aged 7 to &lt;18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
          </group>
          <group group_id="O5">
            <title>POS 18 TID 2 to &lt;7 Years</title>
            <description>Participants aged 2 to &lt;7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.</description>
          </group>
          <group group_id="O6">
            <title>POS 18 TID 7 to &lt;18 Years</title>
            <description>Participants aged 7 to &lt;18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.</description>
          </group>
          <group group_id="O7">
            <title>POS 12 TID 3 Months to &lt;2 Years</title>
            <description>Participants aged 3 months to &lt;2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Adverse Event Leading to Study Drug Discontinuation</title>
          <description>An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.</description>
          <population>The population analyzed was all treated participants.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="19"/>
                <count group_id="O4" value="28"/>
                <count group_id="O5" value="15"/>
                <count group_id="O6" value="30"/>
                <count group_id="O7" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="6"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All AEs: from Day 1 up to Day 39; SAEs: up to Day 58.</time_frame>
      <desc>The population analyzed is all treated participants.</desc>
      <group_list>
        <group group_id="E1">
          <title>POS 12 BID 2 to &lt;7 Yrs</title>
          <description>Participants aged 2 to &lt;7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
        </group>
        <group group_id="E2">
          <title>POS 12 BID 7 to &lt;18 Yrs</title>
          <description>Participants aged 7 to &lt;18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
        </group>
        <group group_id="E3">
          <title>POS 18 BID 2 to &lt;7 Yrs</title>
          <description>Participants aged 2 to &lt;7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
        </group>
        <group group_id="E4">
          <title>POS 18 BID 7 to &lt;18 Yrs</title>
          <description>Participants aged 7 to &lt;18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.</description>
        </group>
        <group group_id="E5">
          <title>POS 18 TID 2 to &lt;7 Yrs</title>
          <description>Participants aged 2 to &lt;7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.</description>
        </group>
        <group group_id="E6">
          <title>POS 18 TID 7 to &lt;18 Yrs</title>
          <description>Participants aged 7 to &lt;18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.</description>
        </group>
        <group group_id="E7">
          <title>POS 12 TID 3 Months to &lt;2 Yrs</title>
          <description>Participants aged 3 months to &lt;2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA version 18.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="15"/>
                <counts group_id="E6" subjects_affected="11" subjects_at_risk="30"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E5" events="7" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E6" events="5" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" 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="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothermia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Multi-organ failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hepatic vein occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hepatobiliary disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Venoocclusive liver disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Catheter site cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pneumonia klebsiella</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Puncture site infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" 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="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Streptococcal bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Chemotherapeutic drug level increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Electrocardiogram T wave inversion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Burkitt's lymphoma recurrent</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" 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="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" 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>Menorrhagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" 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>Acute respiratory distress syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" 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>Skin lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA version 18.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="26" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="13" subjects_at_risk="15"/>
                <counts group_id="E6" subjects_affected="28" subjects_at_risk="30"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" events="6" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E4" events="12" subjects_affected="8" subjects_at_risk="28"/>
                <counts group_id="E5" events="11" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E6" events="12" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Coagulopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E5" events="5" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E6" events="5" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="19" subjects_affected="8" subjects_at_risk="22"/>
                <counts group_id="E2" events="15" subjects_affected="7" subjects_at_risk="21"/>
                <counts group_id="E3" events="10" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E4" events="22" subjects_affected="6" subjects_at_risk="28"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="8" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="4" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Antithrombin III deficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" 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>Ear pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival hyperaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Eye movement disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Eye pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Eye swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Eyelid oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Photophobia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="22"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E6" events="5" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="5" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="22"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E3" events="5" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="28"/>
                <counts group_id="E5" events="7" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E6" events="5" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Frequent bowel movements</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Gingival pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Lip dry</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Loose tooth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="8" subjects_affected="5" subjects_at_risk="22"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E3" events="5" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E4" events="9" subjects_affected="9" subjects_at_risk="28"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E6" events="21" subjects_affected="13" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Proctitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Retching</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E5" events="9" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E6" events="8" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Tongue coated</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="13" subjects_affected="8" subjects_at_risk="22"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="19"/>
                <counts group_id="E4" events="14" subjects_affected="11" subjects_at_risk="28"/>
                <counts group_id="E5" events="11" subjects_affected="7" subjects_at_risk="15"/>
                <counts group_id="E6" events="14" subjects_affected="9" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Proctalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Catheter site erythema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Catheter site pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Device occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="7" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="22"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E3" events="5" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="14" subjects_affected="13" subjects_at_risk="22"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="21"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E4" events="10" subjects_affected="8" subjects_at_risk="28"/>
                <counts group_id="E5" events="4" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E6" events="7" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vessel puncture site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Local swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Engraftment syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Graft versus host disease in skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Alpha haemolytic streptococcal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" 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="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pseudomonal bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vulvitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" 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="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Streptococcal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Viraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" 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>Allergic transfusion reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Procedural headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Transfusion reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" 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="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E5" events="5" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="5" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Biopsy skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="4" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Electrocardiogram QT prolonged</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="3" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Fluid balance positive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>International normalised ratio decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="5" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="4" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="11" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="5" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E6" events="11" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="4" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" 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>Decreased appetite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E6" events="9" subjects_affected="8" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hyperalbuminaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="4" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypertriglyceridaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="4" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="6" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="6" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E6" events="3" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="3" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" 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>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E6" events="4" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E7" 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="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="10" subjects_affected="8" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal behavior</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hallucination</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" 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="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" 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>Dysuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" 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>Genital pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Genital rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pruritus genital</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Genital ulceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Penile oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" 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>Cough</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E7" 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="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="4" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Tachypnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" 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="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" 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="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" 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>Alopecia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Petechiae</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="5" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E5" events="5" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E6" events="5" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Red man syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dermatitis diaper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Central venous catheter removal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Central venous catheterisation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" 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="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Venoocclusive disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pallor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E7" events="0" subjects_affected="0" 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>The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study. The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts and the right to review and comment on the data analysis and presentation with regard to proprietary information, accuracy, fair balance, and compliance.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Only 1 participant was enrolled in the POS 12 TID 3 months to &lt;2 years group, limiting conclusions that may be drawn for pharmacokinetics or safety.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme Corp.</organization>
      <phone>1-800-672-6372</phone>
      <email>ClinicalTrialsDisclosure@merck.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/NCT01716234
org study id: P03579
secondary id: 2007-004645-15
secondary id: MK-5592-032
nct id: NCT01716234
lead sponsor: 
has dmc: Yes
The purpose of this dose-escalation study is to evaluate the pharmacokinetics, safety, and
      tolerability of oral posaconazole in immunocompromised children with neutropenia or expected
      neutropenia.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)
time frame: Up to 12 hours after the first dose (BID dose groups) or up to 8 hours after the first dose (TID dose (TID dose groups)
description: Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 1. The 12-hour sample was not obtained for the TID dose groups. Day 1 pharmacokinetic samples were not collected for participants 3 months to <2 years of age weighing <6.5 kg.
measure: Average Concentration of Posaconazole (Cavg) on Day 7 (Steady State)
time frame: Up to 12 hours after the first dose on Day 7 (BID dose groups) or up to 8 hours after the first dose on Day 7 (TID dose
description: Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 7 (steady state). The 12-hour sample was not obtained for the TID dose groups. The target Cavg range was 500 to <2500 ng/mL.
measure: Number of Participants With an Adverse Event
time frame: Up to Day 58
description: An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.
measure: Number of Participants With an Adverse Event Leading to Study Drug Discontinuation
time frame: Up to Day 28
description: An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.
arm group label: POS 12 BID 2 to <7 Years
arm group type: Experimental
description: Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
arm group label: POS 12 BID 7 to <18 Years
arm group type: Experimental
description: Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
arm group label: POS 18 BID 2 to <7 Years
arm group type: Experimental
description: Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
arm group label: POS 18 BID 7 to <18 Years
arm group type: Experimental
description: Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
arm group label: POS 18 TID 2 to <7 Years
arm group type: Experimental
description: Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
arm group label: POS 18 TID 7 to <18 Years
arm group type: Experimental
description: Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
arm group label: POS 12 TID 3 months to <2 Years
arm group type: Experimental
description: Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
intervention type: Drug
intervention name: Posaconazole 12 mg/kg/day BID
description: Posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) (maximum 800 mg/day)
arm group label: POS 12 BID 2 to <7 Years
arm group label: POS 12 BID 7 to <18 Years
other name: SCH 056592
other name: MK-5592
other name: Noxafil®
intervention type: Drug
intervention name: Posaconazole 18 mg/kg/day BID
description: Posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) (maximum 1200 mg/day)
arm group label: POS 18 BID 2 to <7 Years
arm group label: POS 18 BID 7 to <18 Years
other name: SCH 056592
other name: MK-5592
other name: Noxafil®
intervention type: Drug
intervention name: Posaconazole 18 mg/kg/day TID
description: Posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) (maximum 1200 mg/day)
arm group label: POS 18 TID 2 to <7 Years
arm group label: POS 18 TID 7 to <18 Years
other name: SCH 056592
other name: MK-5592
other name: Noxafil®
intervention type: Drug
intervention name: Posaconazole 12 mg/kg/day TID
description: Posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) (maximum 800 mg/day)
arm group label: POS 12 TID 3 months to <2 Years
other name: SCH 056592
other name: MK-5592
other name: Noxafil®
criteria: 
gender: All
minimum age: 3 Months
maximum age: 17 Years
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
country: Canada
country: Germany
country: Greece
country: Netherlands
country: United States
responsible party type: Sponsor
mesh term: Mycoses
mesh term: Posaconazole
sharing ipd: Yes
ipd description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Only 1 participant was enrolled in the POS 12 TID 3 months to <2 years group, limiting conclusions that may be drawn for pharmacokinetics or safety.
point of contact: 