<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/NCT01687400</url>
  </required_header>
  <id_info>
    <org_study_id>201210102</org_study_id>
    <nct_id>NCT01687400</nct_id>
  </id_info>
  <brief_title>Genomic Predictors of Decitabine Response in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes</brief_title>
  <official_title>Genomic Predictors of Decitabine Response in AML/MDS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial studies potential genetic markers which might be used to predict which&#xD;
      patients with acute myeloid leukemia or myelodysplastic syndromes respond to decitabine. This&#xD;
      study will contribute to the efforts to find effective and less toxic therapies to provide&#xD;
      durable remissions in a significant proportion of elderly AML patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 12, 2013</start_date>
  <completion_date type="Actual">November 13, 2017</completion_date>
  <primary_completion_date type="Actual">June 23, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation of Patient Specific Mutations With Overall Response Rate</measure>
    <time_frame>4 months (4 treatment cycles)</time_frame>
    <description>-Best response after 4 treatment cycles as assessed according to International Working Group (IWG) criteria; bone marrow for gene sequencing will be collected at baseline; mutations will be correlated with overall response rate&#xD;
--Complete remission (CR), Complete remission with incomplete hematologic recovery (CRi), Marrow complete remission (mCR), Partial remission (PR), Stable disease (SD), Progressive disease (PD)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare Outcomes of a 10-day Decitabine Per Cycle Regimen to a 5-day Regimen (Historical Controls)</measure>
    <time_frame>4 months (4 treatment cycles)</time_frame>
    <description>The overall response rate (CR/CRi/mCR/PR) and complete response rate (CR/CRi/mCR) will be compared with historical controls. Response assessed according to IWG criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Mutation Clearance During Treatment</measure>
    <time_frame>Up to Day 56</time_frame>
    <description>Samples collected at baseline and after 10, 28 and 56 days of therapy; the rate of mutation clearance was measured as mean VAF change per day of treatment and was estimated using linear mixed model for repeated measurement data .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peripheral Blood Decitabine Plasma Levels</measure>
    <time_frame>Day 4</time_frame>
    <description>To determine whether steady state serum concentrations of decitabine correlated with responses&#xD;
Complete remission (CR), Complete remission with incomplete hematologic recovery (CRi), Partial remission (PR), Stable disease (SD), Progressive disease (PD), Not applicable (NA) - assessed according to International Working Group (IWG) criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Bone Marrow Methylcytosine</measure>
    <time_frame>Baseline and Day 10</time_frame>
    <description>-Change of total bone marrow deoxyribonucleic acid (DNA) methylcytosine from baseline to Day 10</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">114</enrollment>
  <condition>Leukemia, Myeloid, Acute</condition>
  <condition>Myelodysplastic Syndromes</condition>
  <arm_group>
    <arm_group_label>Decitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>decitabine</intervention_name>
    <arm_group_label>Decitabine</arm_group_label>
    <other_name>5-aza-dCyd, 5AZA, DAC, Dacogen, deoxyazacytidine, dezocitidine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All of the following:&#xD;
&#xD;
          -  Patient must have non-M3 AML or MDS&#xD;
&#xD;
          -  An adverse risk karyotype defined by:&#xD;
&#xD;
               -  Complex karyotype by cytogenetics, or&#xD;
&#xD;
               -  Deletion of all or part of chromosome 5, 7, 12, or 17 defined by FISH or&#xD;
                  cytogenetics, or&#xD;
&#xD;
               -  Somatic TP53 mutation&#xD;
&#xD;
        All of the following:&#xD;
&#xD;
          1. Patient must have an ECOG performance status ≤ 2.&#xD;
&#xD;
          2. Patient must have &gt;10% disease burden measured by cytomorphology, flow cytometry, or&#xD;
             cytogenetics.&#xD;
&#xD;
          3. Patient must have peripheral white blood cell count &lt; 50,000/mcl.&#xD;
&#xD;
          4. Patient must have adequate organ function, defined as:&#xD;
&#xD;
               1. Total bilirubin &lt; 1.5 x ULN&#xD;
&#xD;
               2. AST/ALT &lt; 2.5 x ULN&#xD;
&#xD;
               3. Serum creatinine &lt; 2.0 x ULN&#xD;
&#xD;
          5. Patient must have undergone ≤ 2 cycles of prior hypomethylating agent (decitabine or&#xD;
             azacitidine).&#xD;
&#xD;
          6. Patient must be enrolled in HRPO# 201011766 (&quot;Tissue Acquisition for Analysis of&#xD;
             Genetic Progression Factors in Hematologic Diseases&quot;).&#xD;
&#xD;
          7. Patient must be &gt; 18 years of age.&#xD;
&#xD;
          8. Patient must be able to understand and willing to sign an IRB-approved written&#xD;
             informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient must not be pregnant or nursing&#xD;
&#xD;
          -  Patient must not have acute promyelocytic leukemia or t(15;17) observed by FISH.&#xD;
&#xD;
          -  Patient must not have known central nervous system (CNS) leukemia&#xD;
&#xD;
          -  Patient must not have a history of positive human immunodeficiency virus (HIV)&#xD;
             serology&#xD;
&#xD;
          -  Patient must not have a history of positive hepatitis C serology&#xD;
&#xD;
          -  Patient must not have undergone prior allogeneic stem cell transplant&#xD;
&#xD;
          -  Patient must not have any uncontrolled intercurrent illness including, but not limited&#xD;
             to, ongoing or active infection, ongoing or active graft-versus-host disease (GVHD),&#xD;
             congestive heart failure of New York Heart Association (NYHA) class 3 or 4, unstable&#xD;
             angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that&#xD;
             would limit compliance with study requirements&#xD;
&#xD;
          -  Patient must not have had radiation therapy within 14 days of enrollment&#xD;
&#xD;
          -  Patient must not have received any chemotherapy within 21 days of enrollment and any&#xD;
             acute treatment-related toxicities must have returned to baseline. Patients may be&#xD;
             receiving hydrea at time of enrollment.&#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>Welch John, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.siteman.wustl.edu</url>
    <description>Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine</description>
  </link>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <results_first_submitted>June 13, 2018</results_first_submitted>
  <results_first_submitted_qc>September 5, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 2, 2018</results_first_posted>
  <last_update_submitted>September 5, 2018</last_update_submitted>
  <last_update_submitted_qc>September 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Preleukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Decitabine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 15, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT01687400/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study opened to participant enrollment on 02/12/2013 and closed to participant enrollment on 06/19/2017.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Decitabine</title>
          <description>Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="114"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="114"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Decitabine</title>
          <description>Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="114"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73" lower_limit="31" upper_limit="88"/>
                  </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="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="90"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="105"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Correlation of Patient Specific Mutations With Overall Response Rate</title>
        <description>-Best response after 4 treatment cycles as assessed according to International Working Group (IWG) criteria; bone marrow for gene sequencing will be collected at baseline; mutations will be correlated with overall response rate&#xD;
--Complete remission (CR), Complete remission with incomplete hematologic recovery (CRi), Marrow complete remission (mCR), Partial remission (PR), Stable disease (SD), Progressive disease (PD)</description>
        <time_frame>4 months (4 treatment cycles)</time_frame>
        <population>-Some participants were not evaluable for this outcome measure due to sample collection quality issues and if they had repeat bone marrow biopsies and could be evaluated for responses.</population>
        <group_list>
          <group group_id="O1">
            <title>Decitabine (Participants With Response of CR/CRi/mCR/PR)</title>
            <description>Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O2">
            <title>Decitabine (Participants With Response of SD/PD)</title>
            <description>Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation of Patient Specific Mutations With Overall Response Rate</title>
          <description>-Best response after 4 treatment cycles as assessed according to International Working Group (IWG) criteria; bone marrow for gene sequencing will be collected at baseline; mutations will be correlated with overall response rate&#xD;
--Complete remission (CR), Complete remission with incomplete hematologic recovery (CRi), Marrow complete remission (mCR), Partial remission (PR), Stable disease (SD), Progressive disease (PD)</description>
          <population>-Some participants were not evaluable for this outcome measure due to sample collection quality issues and if they had repeat bone marrow biopsies and could be evaluated for responses.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TP53</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ASXL1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SRSF2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IDH2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DNMT3A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF3B1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RUNX1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TET2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IDH1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NPM1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NRAS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>U2AF1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MY05B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WT1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis #1 is for the genetic mutation TP53.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.035</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis #2 is for ASXL1 genetic mutation</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.72</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis #3 is for SRSF2 genetic mutation</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.28</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis #4 is for IDH2 genetic mutation</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.14</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis #5 is for DNMT3A genetic mutation</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.3</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis #6 is for SF3B1 genetic mutation</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.183</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis #7 is for RUNX1 genetic mutation</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.42</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis #8 is for TET2 genetic mutation</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.36</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis #9 is for IDH1 genetic mutation</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis #10 is for NPM1 genetic mutation</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>1</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis #11 is for NRAS genetic mutation</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.17</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>-Statistical analysis #12 is for U2AF1 genetic mutation</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>1</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis #13 is for MY05B genetic mutation</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.6</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis #14 is for WT1 genetic mutation</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>1</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Compare Outcomes of a 10-day Decitabine Per Cycle Regimen to a 5-day Regimen (Historical Controls)</title>
        <description>The overall response rate (CR/CRi/mCR/PR) and complete response rate (CR/CRi/mCR) will be compared with historical controls. Response assessed according to IWG criteria.</description>
        <time_frame>4 months (4 treatment cycles)</time_frame>
        <population>-Participants were evaluable for this outcome measure if they completed at least one cycle of treatment and the cycle 1 day 28 bone marrow biopsy to assess response</population>
        <group_list>
          <group group_id="O1">
            <title>Decitabine</title>
            <description>Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Compare Outcomes of a 10-day Decitabine Per Cycle Regimen to a 5-day Regimen (Historical Controls)</title>
          <description>The overall response rate (CR/CRi/mCR/PR) and complete response rate (CR/CRi/mCR) will be compared with historical controls. Response assessed according to IWG criteria.</description>
          <population>-Participants were evaluable for this outcome measure if they completed at least one cycle of treatment and the cycle 1 day 28 bone marrow biopsy to assess response</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="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall response rate (CR, CRi/mCR/PR)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.42" lower_limit="65.20" upper_limit="83.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Complete response rate (CR, CRi, mCR)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.95" lower_limit="53.81" upper_limit="74.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>-The historical control of a 5-day regimen (Cashen et al 2010 JCO = NCT00358644) showed 25% (14 out of 55 participants) in overall response rate</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Chi-squared</method>
            <method_desc>1-sample Chi-square test to compare the overall response rate (ORR) to historical control (with ORR=0.25)</method_desc>
            <param_type>Overall Response Rate-for current study</param_type>
            <param_value>0.744</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.652</ci_lower_limit>
            <ci_upper_limit>0.836</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>-The historical control of a 5-day regimen (Cashen et al 2010 JCO = NCT00358644) showed 24% (13 out of 55 participants) in complete response rate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Chi-squared</method>
            <method_desc>1-sample Chi-square test to compare the complete response rate to historical control (with CR=0.24)</method_desc>
            <param_type>Complete response rate-for current study</param_type>
            <param_value>0.640</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.538</ci_lower_limit>
            <ci_upper_limit>0.741</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Mutation Clearance During Treatment</title>
        <description>Samples collected at baseline and after 10, 28 and 56 days of therapy; the rate of mutation clearance was measured as mean VAF change per day of treatment and was estimated using linear mixed model for repeated measurement data .</description>
        <time_frame>Up to Day 56</time_frame>
        <population>-The first 39 cases with adequate samples were serially evaluated with enhanced exome sequencing. The investigators evaluated 15 additional cases using gene panel sequencing.</population>
        <group_list>
          <group group_id="O1">
            <title>Decitabine</title>
            <description>Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Mutation Clearance During Treatment</title>
          <description>Samples collected at baseline and after 10, 28 and 56 days of therapy; the rate of mutation clearance was measured as mean VAF change per day of treatment and was estimated using linear mixed model for repeated measurement data .</description>
          <population>-The first 39 cases with adequate samples were serially evaluated with enhanced exome sequencing. The investigators evaluated 15 additional cases using gene panel sequencing.</population>
          <units>proportion of variant alleles per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TP53</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.781" spread="0.4423"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SRSF2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2214" spread="0.2705"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DNMT3A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2122" spread="0.2817"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IDH2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.08344" spread="0.2841"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RUNX1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2641" spread="0.6536"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TET2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.07478" spread="0.3164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ASXL1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3898" spread="0.3791"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IDH1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1103" spread="0.196"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NRAS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04544" spread="0.2554"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF3B1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.719" spread="0.3481"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peripheral Blood Decitabine Plasma Levels</title>
        <description>To determine whether steady state serum concentrations of decitabine correlated with responses&#xD;
Complete remission (CR), Complete remission with incomplete hematologic recovery (CRi), Partial remission (PR), Stable disease (SD), Progressive disease (PD), Not applicable (NA) - assessed according to International Working Group (IWG) criteria</description>
        <time_frame>Day 4</time_frame>
        <population>The first 45 participants enrolled with adequate samples were analyzed using GC-MS quantification of serum decitabine levels. Sufficient funds were lacking to complete the analysis of additional participants and all participants with data analyzed are reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Decitabine</title>
            <description>Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Peripheral Blood Decitabine Plasma Levels</title>
          <description>To determine whether steady state serum concentrations of decitabine correlated with responses&#xD;
Complete remission (CR), Complete remission with incomplete hematologic recovery (CRi), Partial remission (PR), Stable disease (SD), Progressive disease (PD), Not applicable (NA) - assessed according to International Working Group (IWG) criteria</description>
          <population>The first 45 participants enrolled with adequate samples were analyzed using GC-MS quantification of serum decitabine levels. Sufficient funds were lacking to complete the analysis of additional participants and all participants with data analyzed are reported.</population>
          <units>ng/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CR</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140.5" spread="53.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CRi</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117.2" spread="54.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.71" spread="56.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SD</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="145" spread="73.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PD</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="298.5" spread="213.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.64" spread="58.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Bone Marrow Methylcytosine</title>
        <description>-Change of total bone marrow deoxyribonucleic acid (DNA) methylcytosine from baseline to Day 10</description>
        <time_frame>Baseline and Day 10</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Decitabine (CR/CRi/mCR)</title>
            <description>Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O2">
            <title>Decitabine (PR/SD/PD)</title>
            <description>Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Bone Marrow Methylcytosine</title>
          <description>-Change of total bone marrow deoxyribonucleic acid (DNA) methylcytosine from baseline to Day 10</description>
          <units>proportion of methylcytosine</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.53" spread="0"/>
                    <measurement group_id="O2" value="0.5374" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4416" spread="0.0247"/>
                    <measurement group_id="O2" value="0.4639" spread="0.035"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>-Adverse events were collected from the start of treatment until 30 days following the last day of study treatment (average 5 months) -All deaths were collected from enrollment through study completion date.</time_frame>
      <desc>Grades 1-5 adverse events will be recorded for the first 50 enrolled participants. Grades 3-5 will be recorded for the remainder of enrolled participants (n=64).</desc>
      <group_list>
        <group group_id="E1">
          <title>Decitabine (First 50 Enrolled Patients)</title>
          <description>Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.</description>
        </group>
        <group group_id="E2">
          <title>Decitabine (Remainder of Enrolled Patients n=64)</title>
          <description>Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="43" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="42" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="47" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Heart failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>NSTEMI</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>STEMI</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Central retinal venous occlusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hematemesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Mucositis - oral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Edema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Progressive disease/death</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacteremia - Coagulase negative staphylococcus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bacteremia - E. coli</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bacteremia - ESBL E. coli</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bacteremia - Enterococcus faecium</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bacteremia - Klebsiella pneumoniae</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bacteremia - Micrococcus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bacteremia - Staphylococcus capitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bacteremia - Staphylococcus epidermis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bacteremia - Staphylococcus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bacteremia - Streptococcus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bacteremia - Streptococcus mitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bacteremia - VRE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bacteremia - gram negative</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bone infection - Osteomyelitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>C. difficile</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Catheter related infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Cellulitis infection/pneumonia infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Dental infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Diverticulitis infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Endovascular infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Fusarium fungemia infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Iletitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Parainfluenza infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Septic arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Submandicular sialadenitis infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Upper respiratory infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Upper respiratory infection - parainfluenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bacteremia - Streptococcus mitis/oralis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Myositis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Intracranial hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute hypoxemic respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Sweet's syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="50" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="64" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Lymph node pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Submandibular lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Electrocardiogram QT corrected interval prolonged</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Heart failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Left ventricular systolic dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pericardial tamponade</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Ventricular ectopy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear congestion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hearing impaired</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blurred vision</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Floaters</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Photophobia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Vision changes unspecified</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Vision loss partial (temporary)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Anal mucositis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bloating</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Burping</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Diverticulosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Esophagitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Fecal incontinence</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Gastric hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Gastrointestinal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hiatal hernia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hypothermia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Mucositis - oral</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Oral hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pancreatic cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Small bowel obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Typhlitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Edema face</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Edema limbs</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Facial pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Localized edema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergic reaction</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacteremia (Gram negative)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bacteremia - Escherichia coli/Pseudomonus aeruginosa</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bacteremia - Myobacterium abscessus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bacteremia - Pseudomonas aeruginosa</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bacteremia - Staphylococcus epidermidis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bacteremia - Streptococcus mitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bacteremia - Streptococcus mitis/Coagulase negative staphylococcus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>C. difficile</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Candidal intertrigo (genital)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Catheter related infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Fungal abscess brain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Fungal infection - spleen and liver</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Gastroenteritis (viral)</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Gum infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>HSV infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Infection mouth lesion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Infective myositis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Joint infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Oral buccosal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Oral thrush</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Otitis externa</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Perineal folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Preseptal cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Salivary gland infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Septic arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Upper respiratory infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Vaginal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Bruising</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Burn</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hemorrhage from bronchoscopy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hip pain following bone marrow biopsy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Postoperative hemmorhage</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Activated partial thromboplastin time prolonged</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Cardiac troponin I increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Cardiac troponin T increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Electrocardiogram QT corrected interval prolonged</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>INR increased</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Lymphocyte count increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="38" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="47" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Weight gain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Weight loss</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>White blood cell decreased</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="54" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Acidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hypercalcemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hypermagnesemia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hypernatremia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hyperuricemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hypoalbuminemia</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hypomagnesemia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hypophosphatemia</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bone spur</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Degenerative disc disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Generalized muscle weakness</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hand cramps</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Joint effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Muscle cramps</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Burning sensation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Cognitive impairment acute worsening from baseline</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Facial muscle weakness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Peripheral motor neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Restless leg syndrome</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Sinus pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Altered mental status</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Confusion</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hallucinations</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Acute renal failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bladder spasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Urinary frequency</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Urinary tract pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Penile pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Vaginal hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Allergic rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Aspiration</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Bronchopulmonary hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Diffuse aveolar hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hoarseness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Postnasal drip</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pulmonary edema</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pulmonary hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Rhinorrhea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Sore throat</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hot flashes</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Papulopustular rash</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Purpura</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Rash acneiform</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Skin nodules</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Skin ulceration</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Superficial thrombophlebitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>John Welch, M.D., Ph.D.</name_or_title>
      <organization>Washington University School of Medicine</organization>
      <phone>314-362-2626</phone>
      <email>jwelch@wustl.edu</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/NCT01687400
org study id: 201210102
nct id: NCT01687400
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This clinical trial studies potential genetic markers which might be used to predict which
      patients with acute myeloid leukemia or myelodysplastic syndromes respond to decitabine. This
      study will contribute to the efforts to find effective and less toxic therapies to provide
      durable remissions in a significant proportion of elderly AML patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Correlation of Patient Specific Mutations With Overall Response Rate
time frame: 4 months (4 treatment cycles)
description: -Best response after 4 treatment cycles as assessed according to International Working Group (IWG) criteria; bone marrow for gene sequencing will be collected at baseline; mutations will be correlated with overall response rate
--Complete remission (CR), Complete remission with incomplete hematologic recovery (CRi), Marrow complete remission (mCR), Partial remission (PR), Stable disease (SD), Progressive disease (PD)
measure: Compare Outcomes of a 10-day Decitabine Per Cycle Regimen to a 5-day Regimen (Historical Controls)
time frame: 4 months (4 treatment cycles)
description: The overall response rate (CR/CRi/mCR/PR) and complete response rate (CR/CRi/mCR) will be compared with historical controls. Response assessed according to IWG criteria.
measure: Rate of Mutation Clearance During Treatment
time frame: Up to Day 56
description: Samples collected at baseline and after 10, 28 and 56 days of therapy; the rate of mutation clearance was measured as mean VAF change per day of treatment and was estimated using linear mixed model for repeated measurement data .
measure: Peripheral Blood Decitabine Plasma Levels
time frame: Day 4
description: To determine whether steady state serum concentrations of decitabine correlated with responses
Complete remission (CR), Complete remission with incomplete hematologic recovery (CRi), Partial remission (PR), Stable disease (SD), Progressive disease (PD), Not applicable (NA) - assessed according to International Working Group (IWG) criteria
measure: Change in Bone Marrow Methylcytosine
time frame: Baseline and Day 10
description: -Change of total bone marrow deoxyribonucleic acid (DNA) methylcytosine from baseline to Day 10
arm group label: Decitabine
arm group type: Experimental
description: Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.
intervention type: Drug
intervention name: decitabine
arm group label: Decitabine
other name: 5-aza-dCyd, 5AZA, DAC, Dacogen, deoxyazacytidine, dezocitidine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Welch John, M.D., Ph.D.
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
country: United States
url: http://www.siteman.wustl.edu
description: Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Preleukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Myelodysplastic Syndromes
mesh term: Syndrome
mesh term: Decitabine
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 