<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/NCT01691248</url>
  </required_header>
  <id_info>
    <org_study_id>5119-001</org_study_id>
    <secondary_id>OPT-80-302</secondary_id>
    <nct_id>NCT01691248</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Fidaxomicin Versus Placebo for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (MK-5119-001)</brief_title>
  <acronym>DEFLECT-1</acronym>
  <official_title>DEFLECT-1: A Phase 3b Multi-Center, Double-Blind, Randomized, Placebo Controlled Study to Demonstrate the Safety and Efficacy of Fidaxomicin for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Optimer Pharmaceuticals LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Optimer Pharmaceuticals LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to demonstrate the efficacy and safety of Fidaxomicin versus&#xD;
      placebo for prophylaxis against Clostridium difficile-Associated Diarrhea (CDAD) in adult&#xD;
      participants undergoing hematopoietic stem cell transplantation (HSCT). The primary&#xD;
      hypothesis is that Fidaxomicin is superior to placebo in preventing CDAD in participants&#xD;
      undergoing HSCT.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 10, 2012</start_date>
  <completion_date type="Actual">April 16, 2015</completion_date>
  <primary_completion_date type="Actual">March 18, 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 30 Days Post-treatment Follow-up.</measure>
    <time_frame>Up to 30 days post-treatment</time_frame>
    <description>CDAD is defined as follows: Diarrhea: (change in bowel habits with &gt;3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 60 Days Post-treatment.</measure>
    <time_frame>Up to 60 days post-treatment</time_frame>
    <description>CDAD is defined as follows: Diarrhea: (change in bowel habits with &gt;3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to Day 70 of Study.</measure>
    <time_frame>Up to Day 70 of study</time_frame>
    <description>CDAD is defined as follows: Diarrhea: (change in bowel habits with &gt;3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">611</enrollment>
  <condition>Clostridium Difficile-Associated Diarrhea (CDAD)</condition>
  <arm_group>
    <arm_group_label>Fidaxomicin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>200 mg Fidaxomicin tablet once daily for no longer than 40 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo tablet once daily for no longer than 40 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>fidaxomicin</intervention_name>
    <description>Fidaxomicin 200 mg tablet once daily from the start (+/- 2 days) of condition (prior to transplantation) or at the time of Fluoroquinolone initiation. Study drug treatment will continue until 7 days after either neutrophil engraftment or the completion of any Fluoroquinolone antibiotic regimen (whichever occurs later).&#xD;
Study drug treatment will stop at onset of CDAD or no longer than 40 days of duration, even if other antibiotics are still administered or neutrophil engraftment extends beyond 40 days.</description>
    <arm_group_label>Fidaxomicin</arm_group_label>
    <other_name>DIFICID</other_name>
    <other_name>DIFICLIR</other_name>
    <other_name>OPT-80</other_name>
    <other_name>PAR-101</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo tablet once daily from the start (+/- 2 days) of condition (prior to transplantation) or at the time of Fluoroquinolone initiation. Treatment will continue until 7 days after either neutrophil engraftment or the completion of any Fluoroquinolone antibiotic regimen (whichever occurs later).&#xD;
Treatment will stop at onset of CDAD or no longer than 40 days of duration, even if other antibiotics are still administered or neutrophil engraftment extends beyond 40 days.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female 18 years of age or older.&#xD;
&#xD;
          -  Females of childbearing potential must be using an adequate and reliable method of&#xD;
             contraception (e.g., abstinence, barrier with additional spermicide foam or jelly,&#xD;
             intrauterine device, hormonal contraception). Males and females must agree to avoid&#xD;
             conception during treatment and for four weeks following the end of study treatment.&#xD;
&#xD;
          -  Is undergoing HSCT with planned Fluoroquinolone prophylaxis.&#xD;
&#xD;
          -  Informed consent is provided.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ongoing active CDAD infection (as evidenced by clinical signs of diarrhea along with&#xD;
             the presence of either toxin A and/or B [or their respective genes, tcdA and/or tcdB]&#xD;
             of C. difficile in the stool) or current treatment for CDAD.&#xD;
&#xD;
          -  Undergoing cord blood transplants.&#xD;
&#xD;
          -  Has fulminant colitis, toxic megacolon, or ileus.&#xD;
&#xD;
          -  A history of inflammatory bowel disease (ulcerative colitis or Crohn's disease).&#xD;
&#xD;
          -  Women who are pregnant or are actively breast feeding (all women of childbearing&#xD;
             potential must have a negative pregnancy test result prior to dosing study drug).&#xD;
&#xD;
          -  Use of any drugs potentially useful in the treatment of CDAD (e.g. oral Vancomycin,&#xD;
             Metronidazole, oral Bacitracin, Fusidic Acid, Rifaximin, and Nitazoxanide).&#xD;
&#xD;
          -  Any other condition that, in the opinion of the investigator, would jeopardize the&#xD;
             safety or rights of the participant in the study, would make it unlikely for the&#xD;
             participant to complete the study, or would confound the results of the study.&#xD;
&#xD;
          -  Participation in other clinical research studies utilizing an investigational agent&#xD;
             within one month prior to screening and during the study treatment period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <removed_countries>
    <country>Canada</country>
    <country>United States</country>
  </removed_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <results_first_submitted>March 11, 2016</results_first_submitted>
  <results_first_submitted_qc>March 11, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 12, 2016</results_first_posted>
  <last_update_submitted>August 16, 2018</last_update_submitted>
  <last_update_submitted_qc>August 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Clostridium difficile</keyword>
  <keyword>Clostridium difficile-Associated Diarrhea</keyword>
  <keyword>Prophylaxis</keyword>
  <keyword>Hematopoietic Stem Cell Transplantation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clostridium Infections</mesh_term>
    <mesh_term>Diarrhea</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fidaxomicin</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>
      <group_list>
        <group group_id="P1">
          <title>Fidaxomicin</title>
          <description>200 mg Fidaxomicin tablet once daily for no longer than 40 days</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo tablet once daily for no longer than 40 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="305">Randomized</participants>
                <participants group_id="P2" count="306">Randomized</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="301">Received at least 1 dose of study drug</participants>
                <participants group_id="P2" count="299">Received at least 1 dose of study drug</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="300">A participant randomized to Fidaxomicin, received placebo instead.</participants>
                <participants group_id="P2" count="300">A participant randomized to Fidaxomicin, received placebo instead.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="194"/>
                <participants group_id="P2" count="192"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="111"/>
                <participants group_id="P2" count="114"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Confirmed CDAD</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Reason not provided</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Not Treated</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Modified Intent-to-Treat (mITT) consisting of all randomized participants undergoing hematopoietic stem cell transplantation (HSCT) who received at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Fidaxomicin</title>
          <description>200 mg Fidaxomicin tablet once daily for no longer than 40 days</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo tablet once daily for no longer than 40 days</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="301"/>
            <count group_id="B2" value="299"/>
            <count group_id="B3" value="600"/>
          </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="55.1" spread="12.00"/>
                    <measurement group_id="B2" value="55.1" spread="13.23"/>
                    <measurement group_id="B3" value="55.1" spread="12.62"/>
                  </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="125"/>
                    <measurement group_id="B2" value="103"/>
                    <measurement group_id="B3" value="228"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="176"/>
                    <measurement group_id="B2" value="196"/>
                    <measurement group_id="B3" value="372"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 30 Days Post-treatment Follow-up.</title>
        <description>CDAD is defined as follows: Diarrhea: (change in bowel habits with &gt;3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented.</description>
        <time_frame>Up to 30 days post-treatment</time_frame>
        <population>mITT consisting of all randomized participants undergoing HSCT who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Fidaxomicin</title>
            <description>200 mg Fidaxomicin tablet once daily for no longer than 40 days</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo tablet once daily for no longer than 40 days</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 30 Days Post-treatment Follow-up.</title>
          <description>CDAD is defined as follows: Diarrhea: (change in bowel habits with &gt;3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented.</description>
          <population>mITT consisting of all randomized participants undergoing HSCT who received at least 1 dose of study drug.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="301"/>
                <count group_id="O2" value="299"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.6" lower_limit="23.5" upper_limit="33.7"/>
                    <measurement group_id="O2" value="30.8" lower_limit="25.5" upper_limit="36.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2778</p_value>
            <p_value_desc>1-sided Wald test for a difference in proportions using an unpooled estimate of variance.</p_value_desc>
            <method>One-sided Wald p-value</method>
            <param_type>Percentage Difference</param_type>
            <param_value>2.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.1</ci_lower_limit>
            <ci_upper_limit>9.5</ci_upper_limit>
            <estimate_desc>Placebo minus Fidaxomicin</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 60 Days Post-treatment.</title>
        <description>CDAD is defined as follows: Diarrhea: (change in bowel habits with &gt;3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented.</description>
        <time_frame>Up to 60 days post-treatment</time_frame>
        <population>mITT consisting of all randomized participants undergoing HSCT who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Fidaxomicin</title>
            <description>200 mg Fidaxomicin tablet once daily for no longer than 40 days</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo tablet once daily for no longer than 40 days</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 60 Days Post-treatment.</title>
          <description>CDAD is defined as follows: Diarrhea: (change in bowel habits with &gt;3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented.</description>
          <population>mITT consisting of all randomized participants undergoing HSCT who received at least 1 dose of study drug.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="301"/>
                <count group_id="O2" value="299"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.2" lower_limit="29.8" upper_limit="40.6"/>
                    <measurement group_id="O2" value="35.8" lower_limit="30.4" upper_limit="41.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.4420</p_value>
            <p_value_desc>1-sided Wald test for a difference in proportions using an unpooled estimate of variance.</p_value_desc>
            <method>One-sided Wald p-value</method>
            <param_type>Percentage difference</param_type>
            <param_value>0.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.1</ci_lower_limit>
            <ci_upper_limit>8.2</ci_upper_limit>
            <estimate_desc>Placebo minus Fidaxomicin</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to Day 70 of Study.</title>
        <description>CDAD is defined as follows: Diarrhea: (change in bowel habits with &gt;3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented.</description>
        <time_frame>Up to Day 70 of study</time_frame>
        <population>mITT consisting of all randomized participants undergoing HSCT who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Fidaxomicin</title>
            <description>200 mg Fidaxomicin tablet once daily for no longer than 40 days</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo tablet once daily for no longer than 40 days</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to Day 70 of Study.</title>
          <description>CDAD is defined as follows: Diarrhea: (change in bowel habits with &gt;3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented.</description>
          <population>mITT consisting of all randomized participants undergoing HSCT who received at least 1 dose of study drug.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="301"/>
                <count group_id="O2" value="299"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.2" lower_limit="24.1" upper_limit="34.4"/>
                    <measurement group_id="O2" value="31.1" lower_limit="25.9" upper_limit="36.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.3091</p_value>
            <p_value_desc>1-sided Wald test for a difference in proportions using an unpooled estimate of variance.</p_value_desc>
            <method>One-sided Wald p-value</method>
            <param_type>Percentage difference</param_type>
            <param_value>1.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.5</ci_lower_limit>
            <ci_upper_limit>9.2</ci_upper_limit>
            <estimate_desc>Placebo minus Fidaxomicin</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Non-serious adverse events (AEs) up to 32 days post treatment. Serious AEs (SAEs) up to 62 days post treatment.</time_frame>
      <desc>Participants who received at least one dose of study drug. One participant randomized to Fidaxomicin, received placebo instead.</desc>
      <group_list>
        <group group_id="E1">
          <title>Fidaxomicin</title>
          <description>200 mg Fidaxomicin tablet once daily for no longer than 40 days</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo tablet once daily for no longer than 40 days</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 15.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="98" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="92" subjects_at_risk="300"/>
              </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="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="18" subjects_affected="17" subjects_at_risk="300"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Splenic haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blindness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="300"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="300"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Neutropenic colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="300"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Adverse drug reaction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Multi-organ failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="300"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Systemic inflammatory response syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Hepatic failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Portal hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Venoocclusive liver disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Acute graft versus host disease</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Acute graft versus host disease in intestine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Acute graft versus host disease in skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Engraftment syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Graft versus host disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Graft versus host disease in intestine</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Graft versus host disease in lung</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Graft versus host disease in skin</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Aspergillosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>BK virus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Bacterial infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Bronchopneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Candidiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Cellulitis gangrenous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Cholecystitis infective</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="300"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus viraemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Enterobacter bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Enterobacter sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Enterococcal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Enterococcal sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Escherichia bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Escherichia infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Escherichia sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Gastroenteritis norovirus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Human herpesvirus 6 infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Metapneumovirus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="300"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Pneumonia cytomegaloviral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Pneumonia fungal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Pseudomonal bacteraemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Systemic candida</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Urinary tract infection enterococcal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Viraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Viral haemorrhagic cystitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental overdose</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Drug dispensing error</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Medication error</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Transfusion reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Transplant failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </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="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Blood albumin decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Alkalosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Fluid imbalance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Hypovolaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Tumour lysis syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </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="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Chondrocalcinosis pyrophosphate</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Pathological fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acute lymphocytic leukaemia recurrent</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Acute myeloid leukaemia recurrent</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma pancreas</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Central nervous system lymphoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Diffuse large B-cell lymphoma recurrent</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Leukaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Leukaemia recurrent</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Lymphoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Myelodysplastic syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Non-Hodgkin's lymphoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Non-Hodgkin's lymphoma recurrent</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Peripheral T-cell lymphoma unspecified recurrent</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Post transplant lymphoproliferative disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Autonomic nervous system imbalance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Autonomic neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Leukoencephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Posterior reversible encephalopathy syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Renal failure acute</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Renal failure chronic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </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="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="6" subjects_affected="3" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Organising pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Pulmonary alveolar haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Purpura</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Haemodynamic instability</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Jugular vein thrombosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Venoocclusive disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 15.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="297" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="298" subjects_at_risk="300"/>
              </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="63" subjects_affected="40" subjects_at_risk="300"/>
                <counts group_id="E2" events="52" subjects_affected="36" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="131" subjects_affected="128" subjects_at_risk="300"/>
                <counts group_id="E2" events="107" subjects_affected="98" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="63" subjects_affected="31" subjects_at_risk="300"/>
                <counts group_id="E2" events="65" subjects_affected="40" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="77" subjects_affected="54" subjects_at_risk="300"/>
                <counts group_id="E2" events="77" subjects_affected="46" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" events="14" subjects_affected="13" subjects_at_risk="300"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="39" subjects_affected="30" subjects_at_risk="300"/>
                <counts group_id="E2" events="59" subjects_affected="43" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="17" subjects_affected="16" subjects_at_risk="300"/>
                <counts group_id="E2" events="14" subjects_affected="12" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="71" subjects_affected="62" subjects_at_risk="300"/>
                <counts group_id="E2" events="83" subjects_affected="63" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="20" subjects_affected="20" subjects_at_risk="300"/>
                <counts group_id="E2" events="24" subjects_affected="16" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="59" subjects_affected="55" subjects_at_risk="300"/>
                <counts group_id="E2" events="107" subjects_affected="88" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="286" subjects_affected="211" subjects_at_risk="300"/>
                <counts group_id="E2" events="340" subjects_affected="220" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="24" subjects_affected="22" subjects_at_risk="300"/>
                <counts group_id="E2" events="34" subjects_affected="32" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="47" subjects_affected="44" subjects_at_risk="300"/>
                <counts group_id="E2" events="35" subjects_affected="33" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="300"/>
                <counts group_id="E2" events="19" subjects_affected="18" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="18" subjects_affected="18" subjects_at_risk="300"/>
                <counts group_id="E2" events="27" subjects_affected="26" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="252" subjects_affected="184" subjects_at_risk="300"/>
                <counts group_id="E2" events="284" subjects_affected="201" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" events="29" subjects_affected="29" subjects_at_risk="300"/>
                <counts group_id="E2" events="25" subjects_affected="24" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="89" subjects_affected="68" subjects_at_risk="300"/>
                <counts group_id="E2" events="103" subjects_affected="75" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="174" subjects_affected="119" subjects_at_risk="300"/>
                <counts group_id="E2" events="172" subjects_affected="123" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="31" subjects_affected="22" subjects_at_risk="300"/>
                <counts group_id="E2" events="47" subjects_affected="38" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="33" subjects_affected="28" subjects_at_risk="300"/>
                <counts group_id="E2" events="39" subjects_affected="31" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="138" subjects_affected="117" subjects_at_risk="300"/>
                <counts group_id="E2" events="149" subjects_affected="118" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" events="128" subjects_affected="107" subjects_at_risk="300"/>
                <counts group_id="E2" events="134" subjects_affected="106" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="99" subjects_affected="78" subjects_at_risk="300"/>
                <counts group_id="E2" events="74" subjects_affected="63" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="83" subjects_affected="69" subjects_at_risk="300"/>
                <counts group_id="E2" events="103" subjects_affected="91" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="300"/>
                <counts group_id="E2" events="15" subjects_affected="15" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="15" subjects_affected="12" subjects_at_risk="300"/>
                <counts group_id="E2" events="24" subjects_affected="17" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="16" subjects_affected="13" subjects_at_risk="300"/>
                <counts group_id="E2" events="23" subjects_affected="21" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" events="11" subjects_affected="7" subjects_at_risk="300"/>
                <counts group_id="E2" events="33" subjects_affected="16" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="26" subjects_affected="17" subjects_at_risk="300"/>
                <counts group_id="E2" events="31" subjects_affected="21" subjects_at_risk="300"/>
              </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="117" subjects_affected="97" subjects_at_risk="300"/>
                <counts group_id="E2" events="127" subjects_affected="106" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" events="30" subjects_affected="30" subjects_at_risk="300"/>
                <counts group_id="E2" events="31" subjects_affected="29" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="17" subjects_affected="13" subjects_at_risk="300"/>
                <counts group_id="E2" events="27" subjects_affected="21" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="25" subjects_affected="21" subjects_at_risk="300"/>
                <counts group_id="E2" events="18" subjects_affected="13" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="53" subjects_affected="45" subjects_at_risk="300"/>
                <counts group_id="E2" events="52" subjects_affected="44" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="68" subjects_affected="51" subjects_at_risk="300"/>
                <counts group_id="E2" events="55" subjects_affected="51" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="39" subjects_affected="37" subjects_at_risk="300"/>
                <counts group_id="E2" events="28" subjects_affected="27" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="21" subjects_affected="13" subjects_at_risk="300"/>
                <counts group_id="E2" events="29" subjects_affected="25" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="37" subjects_affected="33" subjects_at_risk="300"/>
                <counts group_id="E2" events="46" subjects_affected="40" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="300"/>
                <counts group_id="E2" events="20" subjects_affected="16" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="34" subjects_affected="28" subjects_at_risk="300"/>
                <counts group_id="E2" events="31" subjects_affected="29" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="53" subjects_affected="44" subjects_at_risk="300"/>
                <counts group_id="E2" events="43" subjects_affected="40" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="37" subjects_affected="31" subjects_at_risk="300"/>
                <counts group_id="E2" events="36" subjects_affected="33" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="91" subjects_affected="75" subjects_at_risk="300"/>
                <counts group_id="E2" events="105" subjects_affected="87" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="24" subjects_affected="22" subjects_at_risk="300"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="300"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="54" subjects_affected="47" subjects_at_risk="300"/>
                <counts group_id="E2" events="42" subjects_affected="39" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="16" subjects_affected="16" subjects_at_risk="300"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="61" subjects_affected="58" subjects_at_risk="300"/>
                <counts group_id="E2" events="67" subjects_affected="62" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="22" subjects_affected="21" subjects_at_risk="300"/>
                <counts group_id="E2" events="25" subjects_affected="23" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="300"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Renal failure acute</sub_title>
                <counts group_id="E1" events="22" subjects_affected="22" subjects_at_risk="300"/>
                <counts group_id="E2" events="30" subjects_affected="23" subjects_at_risk="300"/>
              </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="48" subjects_affected="43" subjects_at_risk="300"/>
                <counts group_id="E2" events="60" subjects_affected="54" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="45" subjects_affected="39" subjects_at_risk="300"/>
                <counts group_id="E2" events="34" subjects_affected="30" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="300"/>
                <counts group_id="E2" events="27" subjects_affected="20" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="21" subjects_affected="19" subjects_at_risk="300"/>
                <counts group_id="E2" events="29" subjects_affected="24" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="300"/>
                <counts group_id="E2" events="19" subjects_affected="19" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="300"/>
                <counts group_id="E2" events="18" subjects_affected="18" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="47" subjects_affected="43" subjects_at_risk="300"/>
                <counts group_id="E2" events="49" subjects_affected="42" subjects_at_risk="300"/>
              </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="19" subjects_affected="17" subjects_at_risk="300"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="21" subjects_affected="20" subjects_at_risk="300"/>
                <counts group_id="E2" events="26" subjects_affected="23" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="19" subjects_affected="18" subjects_at_risk="300"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="38" subjects_affected="32" subjects_at_risk="300"/>
                <counts group_id="E2" events="36" subjects_affected="32" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="63" subjects_affected="52" subjects_at_risk="300"/>
                <counts group_id="E2" events="55" subjects_affected="46" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Rash generalised</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="300"/>
                <counts group_id="E2" events="20" subjects_affected="18" subjects_at_risk="300"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="38" subjects_affected="35" subjects_at_risk="300"/>
                <counts group_id="E2" events="50" subjects_affected="40" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="53" subjects_affected="43" subjects_at_risk="300"/>
                <counts group_id="E2" events="65" subjects_affected="48" subjects_at_risk="300"/>
              </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>Any publication or other public presentation of results from this study requires prior review and written approval of the Sponsor. Draft abstracts, manuscripts, and materials for presentation at scientific meetings should be provided to the Sponsor at least 90 working days prior to abstract or other relevant submission deadlines.</restrictive_agreement>
    </certain_agreements>
    <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/NCT01691248
org study id: 5119-001
secondary id: OPT-80-302
nct id: NCT01691248
lead sponsor: 
has dmc: Yes
The objective of this study is to demonstrate the efficacy and safety of Fidaxomicin versus
      placebo for prophylaxis against Clostridium difficile-Associated Diarrhea (CDAD) in adult
      participants undergoing hematopoietic stem cell transplantation (HSCT). The primary
      hypothesis is that Fidaxomicin is superior to placebo in preventing CDAD in participants
      undergoing HSCT.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 30 Days Post-treatment Follow-up.
time frame: Up to 30 days post-treatment
description: CDAD is defined as follows: Diarrhea: (change in bowel habits with >3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented.
measure: Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 60 Days Post-treatment.
time frame: Up to 60 days post-treatment
description: CDAD is defined as follows: Diarrhea: (change in bowel habits with >3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented.
measure: Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to Day 70 of Study.
time frame: Up to Day 70 of study
description: CDAD is defined as follows: Diarrhea: (change in bowel habits with >3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented.
arm group label: Fidaxomicin
arm group type: Active Comparator
description: 200 mg Fidaxomicin tablet once daily for no longer than 40 days
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo tablet once daily for no longer than 40 days
intervention type: Drug
intervention name: fidaxomicin
description: Fidaxomicin 200 mg tablet once daily from the start (+/- 2 days) of condition (prior to transplantation) or at the time of Fluoroquinolone initiation. Study drug treatment will continue until 7 days after either neutrophil engraftment or the completion of any Fluoroquinolone antibiotic regimen (whichever occurs later).
Study drug treatment will stop at onset of CDAD or no longer than 40 days of duration, even if other antibiotics are still administered or neutrophil engraftment extends beyond 40 days.
arm group label: Fidaxomicin
other name: DIFICID
other name: DIFICLIR
other name: OPT-80
other name: PAR-101
intervention type: Drug
intervention name: Placebo
description: Placebo tablet once daily from the start (+/- 2 days) of condition (prior to transplantation) or at the time of Fluoroquinolone initiation. Treatment will continue until 7 days after either neutrophil engraftment or the completion of any Fluoroquinolone antibiotic regimen (whichever occurs later).
Treatment will stop at onset of CDAD or no longer than 40 days of duration, even if other antibiotics are still administered or neutrophil engraftment extends beyond 40 days.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Clostridium Infections
mesh term: Diarrhea
mesh term: Fidaxomicin
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: 
point of contact: 