<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/NCT01696084</url>
  </required_header>
  <id_info>
    <org_study_id>CLTR0310-301</org_study_id>
    <nct_id>NCT01696084</nct_id>
  </id_info>
  <brief_title>Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia</brief_title>
  <acronym>301</acronym>
  <official_title>Phase III, Multicenter, Randomized, Trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection Versus Cytarabine and Daunorubicin in Patients 60-75 Years of Age With Untreated High Risk (Secondary) AML</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jazz Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Leukemia and Lymphoma Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jazz Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To confirm the efficacy of CPX-351 compared to 7+3 as first line therapy in elderly patients&#xD;
      (60-75 yrs) with high risk (secondary) Acute Myeloid Leukemia. The primary efficacy endpoint&#xD;
      will be overall survival.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 13, 2012</start_date>
  <completion_date type="Actual">December 31, 2015</completion_date>
  <primary_completion_date type="Actual">December 31, 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>From the date of randomization to death from any cause</time_frame>
    <description>Overall survival was measured from the date of randomization to death from any cause, subjects not known to have died by the last follow-up were censored on the date they were last known to be alive.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects With a Response</measure>
    <time_frame>Post Induction</time_frame>
    <description>Complete Remission (CR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event-free Survival</measure>
    <time_frame>From the date of randomization to the date that persistent disease was documented or the date of relapse after CR or death, whichever came first</time_frame>
    <description>All randomized subjects were assessed for event-free survival (EFS). EFS was defined as the time from study randomization to the date of induction treatment failure (persistent disease), relapse from CR or CRi or death from any cause, whichever came first. Subjects alive and not known to have any of these events were censored on thee date they were last examined on study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remission Duration</measure>
    <time_frame>From the date of achievement of a remission until the date of relapse or death from any cause</time_frame>
    <description>Only subjects achieving CR or CRi were assessed for remission duration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Achieving Morphologic Leukemia-free State</measure>
    <time_frame>Day 14</time_frame>
    <description>All randomized subjects with at least 1 evaluable postrandomization bone marrow assessment performed on or after Day 14 after the last induction were assessed for MLFS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects Receiving a Stem Cell Transplant</measure>
    <time_frame>Post Induction</time_frame>
    <description>The number and percentage of subjects transferred for HSCT after induction treatment was recorded.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">309</enrollment>
  <condition>High Risk Acute Myeloid Leukemia</condition>
  <arm_group>
    <arm_group_label>Arm A (CPX-351)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B (7+3)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CPX-351</intervention_name>
    <description>First induction: 100 units/m2 by 90-minute IV infusion on Days 1, 3, 5. Second induction: 100 units/m2 by 90-minute IV infusion on Days 1 and 3. Consolidation therapy: 65 units/m2 by 90-minute IV infusion on Days 1 and 3.</description>
    <arm_group_label>Arm A (CPX-351)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>7+3 (cytarabine and daunorubicin)</intervention_name>
    <description>First induction: 7+3 was administered as: cytarabine at a dose of 100 mg/m2/day on Days 1 through 7 by continuous infusion, and daunorubicin at a dose of 60 mg/m2/day on Days 1, 2, and 3.&#xD;
Second induction: 5+2 was administered as: cytarabine at a dose of 100 mg/m2/day on Days 1 through 5 by continuous infusion and daunorubicin at a dose of 60 mg/m2/day on Days 1 and 2.&#xD;
Consolidation therapy: 5+2 was administered as: cytarabine at a dose of 100 mg/m2/day on Days 1 through 5 by continuous infusion, and daunorubicin at a dose of 60 mg/m2/day on Days 1 and 2.</description>
    <arm_group_label>Arm B (7+3)</arm_group_label>
    <other_name>cytarabine and daunorubicin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to understand and voluntarily give informed consent&#xD;
&#xD;
          -  Age 60-75 years at the time of diagnosis of AML&#xD;
&#xD;
          -  Pathological diagnosis of AML according to WHO criteria (with at least 20% blasts in&#xD;
             the peripheral blood or bone marrow)&#xD;
&#xD;
          -  Confirmation of:&#xD;
&#xD;
               -  Therapy related AML: t-AML must have a documented history of prior cytotoxic&#xD;
                  therapy or ionizing radiotherapy for an unrelated disease&#xD;
&#xD;
               -  AML with a history of myelodysplasia: MDSAML must have bone marrow documentation&#xD;
                  of prior MDS&#xD;
&#xD;
               -  AML with a history of CMMoL: CMMoLAML must have bone marrow documentation of&#xD;
                  prior CMMoL&#xD;
&#xD;
               -  De novo AML with karyotypic abnormalities characteristic of MDS: de novoAML must&#xD;
                  have cytogenetics with abnormalities per WHO.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2&#xD;
&#xD;
          -  Able to adhere to the study visit schedule and other protocol requirements&#xD;
&#xD;
          -  Laboratory values fulfilling the following:&#xD;
&#xD;
               -  Serum creatinine &lt; 2.0 mg/dL&#xD;
&#xD;
               -  Serum total bilirubin &lt; 2.0 mg/dL, patients with Gilbert's Syndrome should&#xD;
                  contact the medical monitor&#xD;
&#xD;
               -  Serum alanine aminotransferase or aspartate aminotransferase &lt; 3 times the ULN&#xD;
                  Note: If elevated liver enzymes, above the ULN, are related to disease; contact&#xD;
                  medical monitor to discuss.&#xD;
&#xD;
          -  Cardiac ejection fraction ≥ 50% by echocardiography or MUGA&#xD;
&#xD;
          -  Patients with second malignancies in remission may be eligible if there is clinical&#xD;
             evidence of disease stability for a period of greater than 6 months off cytotoxic&#xD;
             chemotherapy, documented by imaging, tumor marker studies, etc., at screening.&#xD;
             Patients maintained on long-term non-chemotherapy treatment, e.g., hormonal therapy,&#xD;
             are eligible.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Except for CMMoL, patients with history of myeloproliferative neoplasms (MPN) (defined&#xD;
             as a history of essential thrombocytosis or polycythemia vera, or idiopathic&#xD;
             myelofibrosis prior to the diagnosis of AML) or combined MDS/MPN are not eligible.&#xD;
&#xD;
          -  Acute promyelocytic leukemia [t(15;17)] or favorable cytogenetics, including t(8;21)&#xD;
             or inv16 if known at the time of randomization.&#xD;
&#xD;
          -  Clinical evidence of active CNS leukemia&#xD;
&#xD;
          -  Patients with active (uncontrolled, metastatic) second malignancies are excluded.&#xD;
&#xD;
          -  Prior treatment intended for induction therapy of AML; only hydroxyurea is permitted&#xD;
             for control of blood counts. For example, a patient with MDS that changes HMA dose and&#xD;
             schedule after the diagnosis of AML is excluded. AML-type therapy, such as cytarabine&#xD;
             alone (&gt;1g/m2/day) or cytarabine plus an anthracycline as well as prior HSCT are also&#xD;
             excluded.&#xD;
&#xD;
          -  Administration of any therapy for MDS (conventional or investigational) must be&#xD;
             completed by 2 weeks prior to of the first dose of study drug; in the event of rapidly&#xD;
             proliferative disease use of hydroxyurea is permitted until 24 hours before the start&#xD;
             of study treatment. Toxicities associated with prior MDS therapy must have recovered&#xD;
             to grade 1 or less prior to start of treatment.&#xD;
&#xD;
          -  Any major surgery or radiation therapy within four weeks.&#xD;
&#xD;
          -  Patients with prior cumulative anthracycline exposure of greater than 368 mg/m2&#xD;
             daunorubicin (or equivalent).&#xD;
&#xD;
          -  Any serious medical condition, laboratory abnormality or psychiatric illness that&#xD;
             would prevent obtaining informed consent&#xD;
&#xD;
          -  Patients with myocardial impairment of any cause (e.g. cardiomyopathy, ischemic heart&#xD;
             disease, significant valvular dysfunction, hypertensive heart disease, and congestive&#xD;
             heart failure) resulting in heart failure by New York Heart Association Criteria&#xD;
             (Class III or IV staging)&#xD;
&#xD;
          -  Active or uncontrolled infection. Patients with an infection receiving treatment&#xD;
             (antibiotic, antifungal or antiviral treatment) may be entered into the study but must&#xD;
             be afebrile and hemodynamically stable for ≥72 hrs.&#xD;
&#xD;
          -  Current evidence of invasive fungal infection (blood or tissue culture); patients with&#xD;
             recent fungal infection must have a subsequent negative cultures to be eligible; known&#xD;
             HIV (new testing not required) or evidence of active hepatitis B or C infection (with&#xD;
             rising transaminase values)&#xD;
&#xD;
          -  Hypersensitivity to cytarabine, daunorubicin or liposomal products&#xD;
&#xD;
          -  History of Wilson's disease or other copper-metabolism disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of CA San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92037-0706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. Lee Moffitt Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northside Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Franciscan St. Francis Health</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Missouri</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Shore LIJ Health System</name>
      <address>
        <city>Long Island City</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cornell U, Weill Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Medical College</name>
      <address>
        <city>Valhalla</city>
        <state>New York</state>
        <zip>10595</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599-1651</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest University Health Services</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Portland Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fox Chase Cancer Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarah Cannon Research Institute</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Research Insitute</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>M.D. Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>770303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fred Hutchinson Cancer Research Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Alberta Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2C8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>British Columbia Cancer Center</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Maisonneuve-Rosemont</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <results_first_submitted>September 3, 2017</results_first_submitted>
  <results_first_submitted_qc>September 3, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">October 2, 2017</results_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>AML</keyword>
  <keyword>Acute Myeloid Leukemia</keyword>
  <keyword>high risk AML</keyword>
  <keyword>secondary AML</keyword>
  <keyword>AML in elderly</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cytarabine</mesh_term>
    <mesh_term>Daunorubicin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Arm A (CPX-351)</title>
          <description>Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.</description>
        </group>
        <group group_id="P2">
          <title>Arm B (7+3)</title>
          <description>Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="153"/>
                <participants group_id="P2" count="156"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="131"/>
                <participants group_id="P2" count="146"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Arm A (CPX-351)</title>
          <description>Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.</description>
        </group>
        <group group_id="B2">
          <title>Arm B (7+3)</title>
          <description>Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="153"/>
            <count group_id="B2" value="156"/>
            <count group_id="B3" value="309"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.8" spread="4.19"/>
                    <measurement group_id="B2" value="67.7" spread="4.1"/>
                    <measurement group_id="B3" value="67.7" spread="4.14"/>
                  </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="59"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="119"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                    <measurement group_id="B2" value="96"/>
                    <measurement group_id="B3" value="190"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="128"/>
                    <measurement group_id="B2" value="139"/>
                    <measurement group_id="B3" value="267"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Survival</title>
        <description>Overall survival was measured from the date of randomization to death from any cause, subjects not known to have died by the last follow-up were censored on the date they were last known to be alive.</description>
        <time_frame>From the date of randomization to death from any cause</time_frame>
        <population>Intent-to-Treat (ITT) Population: All participants randomized in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A (CPX-351)</title>
            <description>Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.</description>
          </group>
          <group group_id="O2">
            <title>Arm B (7+3)</title>
            <description>Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival</title>
          <description>Overall survival was measured from the date of randomization to death from any cause, subjects not known to have died by the last follow-up were censored on the date they were last known to be alive.</description>
          <population>Intent-to-Treat (ITT) Population: All participants randomized in the study.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="156"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.56" lower_limit="6.60" upper_limit="11.86"/>
                    <measurement group_id="O2" value="5.95" lower_limit="4.99" upper_limit="7.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects With a Response</title>
        <description>Complete Remission (CR)</description>
        <time_frame>Post Induction</time_frame>
        <population>Intent-to-Treat (ITT) Population: All participants randomized in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A (CPX-351)</title>
            <description>Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.</description>
          </group>
          <group group_id="O2">
            <title>Arm B (7+3)</title>
            <description>Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With a Response</title>
          <description>Complete Remission (CR)</description>
          <population>Intent-to-Treat (ITT) Population: All participants randomized in the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="156"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Event-free Survival</title>
        <description>All randomized subjects were assessed for event-free survival (EFS). EFS was defined as the time from study randomization to the date of induction treatment failure (persistent disease), relapse from CR or CRi or death from any cause, whichever came first. Subjects alive and not known to have any of these events were censored on thee date they were last examined on study.</description>
        <time_frame>From the date of randomization to the date that persistent disease was documented or the date of relapse after CR or death, whichever came first</time_frame>
        <population>Intent-to-Treat (ITT) Population: All participants randomized in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A (CPX-351)</title>
            <description>Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.</description>
          </group>
          <group group_id="O2">
            <title>Arm B (7+3)</title>
            <description>Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.</description>
          </group>
        </group_list>
        <measure>
          <title>Event-free Survival</title>
          <description>All randomized subjects were assessed for event-free survival (EFS). EFS was defined as the time from study randomization to the date of induction treatment failure (persistent disease), relapse from CR or CRi or death from any cause, whichever came first. Subjects alive and not known to have any of these events were censored on thee date they were last examined on study.</description>
          <population>Intent-to-Treat (ITT) Population: All participants randomized in the study.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="156"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.53" lower_limit="2.07" upper_limit="4.99"/>
                    <measurement group_id="O2" value="1.31" lower_limit="1.08" upper_limit="1.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Remission Duration</title>
        <description>Only subjects achieving CR or CRi were assessed for remission duration.</description>
        <time_frame>From the date of achievement of a remission until the date of relapse or death from any cause</time_frame>
        <population>Intent-to-Treat (ITT) Population: All participants randomized in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A (CPX-351)</title>
            <description>Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.</description>
          </group>
          <group group_id="O2">
            <title>Arm B (7+3)</title>
            <description>Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.</description>
          </group>
        </group_list>
        <measure>
          <title>Remission Duration</title>
          <description>Only subjects achieving CR or CRi were assessed for remission duration.</description>
          <population>Intent-to-Treat (ITT) Population: All participants randomized in the study.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="156"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.93" lower_limit="4.60" upper_limit="9.23"/>
                    <measurement group_id="O2" value="6.11" lower_limit="3.45" upper_limit="8.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Achieving Morphologic Leukemia-free State</title>
        <description>All randomized subjects with at least 1 evaluable postrandomization bone marrow assessment performed on or after Day 14 after the last induction were assessed for MLFS.</description>
        <time_frame>Day 14</time_frame>
        <population>Intent-to-Treat (ITT) Population: All participants randomized in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A (CPX-351)</title>
            <description>Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.</description>
          </group>
          <group group_id="O2">
            <title>Arm B (7+3)</title>
            <description>Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Achieving Morphologic Leukemia-free State</title>
          <description>All randomized subjects with at least 1 evaluable postrandomization bone marrow assessment performed on or after Day 14 after the last induction were assessed for MLFS.</description>
          <population>Intent-to-Treat (ITT) Population: All participants randomized in the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
                <count group_id="O2" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87"/>
                    <measurement group_id="O2" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects Receiving a Stem Cell Transplant</title>
        <description>The number and percentage of subjects transferred for HSCT after induction treatment was recorded.</description>
        <time_frame>Post Induction</time_frame>
        <population>Intent-to-Treat (ITT) Population: All participants randomized in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A (CPX-351)</title>
            <description>Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.</description>
          </group>
          <group group_id="O2">
            <title>Arm B (7+3)</title>
            <description>Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects Receiving a Stem Cell Transplant</title>
          <description>The number and percentage of subjects transferred for HSCT after induction treatment was recorded.</description>
          <population>Intent-to-Treat (ITT) Population: All participants randomized in the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="156"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.</time_frame>
      <desc>Safety Population: All randomized participants who received at least one dose of study treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Arm A (CPX-351)</title>
          <description>Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.</description>
        </group>
        <group group_id="E2">
          <title>Arm B (7+3)</title>
          <description>Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="90" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="65" subjects_at_risk="151"/>
              </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="12" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Cardiac Failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Left Ventricular Dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Cardiac Arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Congestive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Cardiomyopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Acute Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Cardio-Respiratory Arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Cardiotoxicity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Cytotoxic Cardiomyopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Mitral Valve Incompetence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Supraventricular Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Ventricular Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Euthyroid Sick Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </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="153"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Small Intestinal Disorders</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Chron's Disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Gastric Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Gingival Bleeding</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Lower Gastrointestinal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Rectal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Disease Progression</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Multi-Organ Failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Chest Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Non-Cardiac Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis Acute</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Bile Duct Stone</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Alloimmunisation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Septic Shock</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Enterococcal Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Staphylococcal Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Lung Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pneumonia Bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Bacteroides Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Bronchopulmonary Aspergillosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Central Nervous System Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Enterobacter Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Escherichia Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Escherichia Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Klebsiella Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Klebsiella Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Mycotic Aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Neutropenic Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pneumonia Fungal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pneumonia Pseudomonas Aeruginosa</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pseudomonal Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Sinusitis Fungal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Skin Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Staphylococcal Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Streptococcal Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Subdural Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Transfusion Reaction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Brain Herniation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Subdural Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Transfusion-Related Acute Lung Injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Ejection Fraction Decreased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Enterococcus Test Positive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Fungal Test Positive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Hepatic Enzyme Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Klebsiella Test Positive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pseudomonas Test Positive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Staphylococcus Test Positive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Stenotrophomonas Test Positive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Streptococcus Test Positive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Lactic Acidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Tumor Lysis Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </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="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acute Myeloid Leukaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Leukaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Acute Myeloid Leukaemia Recurrent</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Myelodysplastic Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Renal Cell Carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Central Nervous System Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Cerebral Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Haemorrhage Intracranial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Carotid Artery Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Cerebral Infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Convulsion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Radiculopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional State</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Mental Status Changes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal Failure Acute</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Acute Respiratory Failure</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pulmonary Oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Respiratory Distress</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Acute Respiratory Distress Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Hypercapnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pleural Effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pneumonia Aspiration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pulmonary Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <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="152" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="151" subjects_at_risk="151"/>
              </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="104" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="105" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Vision Blurred</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="70" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="103" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="75" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="83" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="65" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="60" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Abdominal Distension</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Mouth Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Dry Mouth</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Gingival Bleeding</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Oral Pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal Reflux Disease</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Mouth Ulceration</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" subjects_affected="62" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="76" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="53" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="53" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="41" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Mucosal Inflammation</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Catheter Site Erythema</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Catheter Site Pain</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Chest Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Transfusion Reaction</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Procedural Pain</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight Decreased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased Appetite</sub_title>
                <counts group_id="E1" subjects_affected="50" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="62" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Fluid Overload</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pain In Extremity</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Neck Pain</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Pain</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Muscular Weakness</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="53" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="37" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="38" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Confusional State</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Hallucination</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal Failure Acute</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Urinary Incontinence</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="51" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="54" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pleural Effusion</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Oropharyngeal Pain</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pulmonary Oedema</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Rales</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Tachypnoea</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Nasal Congestion</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Petechiae</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Rash Maculo-Papular</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Night Sweats</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Blood Blister</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Rash Pruritic</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Dry Skin</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Rash Erythematous</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Skin Lesion</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Associate Director, Clinical Trial Disclosure &amp; Transparency</name_or_title>
      <organization>Jazz Pharmaceuticals</organization>
      <phone>2158709177</phone>
      <email>tom.chmielewski@jazzpharma.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01696084
org study id: CLTR0310-301
nct id: NCT01696084
lead sponsor: 
collaborator: 
has dmc: Yes
To confirm the efficacy of CPX-351 compared to 7+3 as first line therapy in elderly patients
      (60-75 yrs) with high risk (secondary) Acute Myeloid Leukemia. The primary efficacy endpoint
      will be overall survival.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Survival
time frame: From the date of randomization to death from any cause
description: Overall survival was measured from the date of randomization to death from any cause, subjects not known to have died by the last follow-up were censored on the date they were last known to be alive.
measure: Proportion of Subjects With a Response
time frame: Post Induction
description: Complete Remission (CR)
measure: Event-free Survival
time frame: From the date of randomization to the date that persistent disease was documented or the date of relapse after CR or death, whichever came first
description: All randomized subjects were assessed for event-free survival (EFS). EFS was defined as the time from study randomization to the date of induction treatment failure (persistent disease), relapse from CR or CRi or death from any cause, whichever came first. Subjects alive and not known to have any of these events were censored on thee date they were last examined on study.
measure: Remission Duration
time frame: From the date of achievement of a remission until the date of relapse or death from any cause
description: Only subjects achieving CR or CRi were assessed for remission duration.
measure: Rate of Achieving Morphologic Leukemia-free State
time frame: Day 14
description: All randomized subjects with at least 1 evaluable postrandomization bone marrow assessment performed on or after Day 14 after the last induction were assessed for MLFS.
measure: Proportion of Subjects Receiving a Stem Cell Transplant
time frame: Post Induction
description: The number and percentage of subjects transferred for HSCT after induction treatment was recorded.
arm group label: Arm A (CPX-351)
arm group type: Experimental
description: Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
arm group label: Arm B (7+3)
arm group type: Active Comparator
description: Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
intervention type: Drug
intervention name: CPX-351
description: First induction: 100 units/m2 by 90-minute IV infusion on Days 1, 3, 5. Second induction: 100 units/m2 by 90-minute IV infusion on Days 1 and 3. Consolidation therapy: 65 units/m2 by 90-minute IV infusion on Days 1 and 3.
arm group label: Arm A (CPX-351)
intervention type: Drug
intervention name: 7+3 (cytarabine and daunorubicin)
description: First induction: 7+3 was administered as: cytarabine at a dose of 100 mg/m2/day on Days 1 through 7 by continuous infusion, and daunorubicin at a dose of 60 mg/m2/day on Days 1, 2, and 3.
Second induction: 5+2 was administered as: cytarabine at a dose of 100 mg/m2/day on Days 1 through 5 by continuous infusion and daunorubicin at a dose of 60 mg/m2/day on Days 1 and 2.
Consolidation therapy: 5+2 was administered as: cytarabine at a dose of 100 mg/m2/day on Days 1 through 5 by continuous infusion, and daunorubicin at a dose of 60 mg/m2/day on Days 1 and 2.
arm group label: Arm B (7+3)
other name: cytarabine and daunorubicin
criteria: 
gender: All
minimum age: 60 Years
maximum age: 75 Years
healthy volunteers: No
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country: Canada
country: United States
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Cytarabine
mesh term: Daunorubicin
participant flow: 
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certain agreements: 
point of contact: 