<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/NCT03303339</url>
  </required_header>
  <id_info>
    <org_study_id>TROV-052</org_study_id>
    <secondary_id>U1111-1201-6416</secondary_id>
    <nct_id>NCT03303339</nct_id>
  </id_info>
  <brief_title>Onvansertib in Combination With Either Low-dose Cytarabine or Decitabine in Adult Patients With Acute Myeloid Leukemia (AML)</brief_title>
  <official_title>A Phase 1b/2 Study of PCM-075 (Onvansertib) in Combination With Either Low-Dose Cytarabine or Decitabine in Subjects With Acute Myeloid Leukemia (AML)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardiff Oncology</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cardiff Oncology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the phase 1b/2 study is to determine whether Onvansertib given orally daily&#xD;
      for 5 consecutive days every 28 days is safe and tolerable in adult patients who have&#xD;
      relapsed/refractory Acute Myeloid Leukemia (AML), or are ineligible for intensive induction&#xD;
      therapy, and to determine the maximum tolerated dose and recommended phase 2 dose of&#xD;
      Onvansertib in combination with decitabine or Onvansertib in combination with low-dose&#xD;
      cytarabine. In the phase 2 portion of the study, Onvansertib in combination with decitabine&#xD;
      will be studied to provide further data on the safety profile of the combination and to&#xD;
      preliminarily assess the activity of the chosen combination in patients with untreated AML&#xD;
      who are not candidates for aggressive induction therapy, or who have received one prior&#xD;
      treatment for their AML.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 17, 2017</start_date>
  <completion_date type="Actual">November 17, 2021</completion_date>
  <primary_completion_date type="Actual">November 17, 2021</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Experienced Dose Limiting Toxicities (DLT)</measure>
    <time_frame>Up to Day 28 of Cycle 1</time_frame>
    <description>Dose-limiting toxicities were defined as events related to onvansertib that were considered an adverse reaction or suspected adverse reaction during the first cycle of therapy and that fulfilled one of the following: Hematologic (persistent pancytopenia resistant to current standards of care that continues for ≥42 days and is not related to leukemic infiltration or another cause unrelated to study therapy) or Non-Hematologic (any Grade 3 abnormalities that persist &gt;7 days without decreasing in severity despite standards of care, are clinically significant, or that are Grade 4 and symptomatic).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status</measure>
    <time_frame>Baseline and end of study (approximately up to up to 27 months)</time_frame>
    <description>ECOG performance status was determined using 6-point scale from 0-5, with 0 meaning a participant was fully active/able to carry on all pre-disease activities without restriction and 5 meaning the participant was deceased.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 2: Number of Participants Who Achieved a Complete Response (CR)</measure>
    <time_frame>Up to 27 months</time_frame>
    <description>Complete Response also includes Complete Response with Incomplete Blood Count Recovery (CRi). Complete response is defined by the following criteria:&#xD;
Morphologic leukemia-free state plus:&#xD;
Subject is independent of transfusions&#xD;
Absolute neutrophil count of &gt;1000/mm3&#xD;
Platelets of ≥100,000/mm3&#xD;
Complete response with incomplete blood count recovery meets all criteria for CR except for either neutropenia (ANC &lt;1000/mm3) or thrombocytopenia (&lt;100,000/mm3) but must include transfusion independence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events (AEs)</measure>
    <time_frame>Baseline up to 30 days after last dose of study drug (up to 27 months)</time_frame>
    <description>Any clinically significant change in electrocardiogram (ECG), physical examination findings, body weight, vital signs, and laboratory parameters were recorded as Adverse Events.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Number of Participants Who Achieved a Morphologic Leukemia-free (MLF) State</measure>
    <time_frame>Up to 27 months</time_frame>
    <description>Defined as bone marrow (BM) &lt;5% blasts in an aspirate with spicules and no blasts with Auer rods or persistence of extramedullary disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Number of Participants With Partial Response (PR)</measure>
    <time_frame>Up to 27 months</time_frame>
    <description>PR criteria includes all of the hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate and a normalization of blood counts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Duration of Response (DOR)</measure>
    <time_frame>Up to 27 months</time_frame>
    <description>Duration of Response (DOR) is the time (in months) from the first response of CR, CRi or PR until recurrence of or progression of disease (or death). MLF State is also included as a response when calculating DOR. Responding subjects without death or progression will be censored at the date of their last evaluable disease assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Event-free Survival (EFS)</measure>
    <time_frame>12 Months</time_frame>
    <description>EFS is defined as the time from enrollment until disease progression or death from any cause and reported as the proportion of participants event free at 12 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Overall Survival (OS)</measure>
    <time_frame>12 Months</time_frame>
    <description>OS is defined as the time from enrollment until death from any cause and reported as the proportion of participants alive at 12 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Parameter: Maximum Observed Plasma Concentration (Cmax) for Onvansertib</measure>
    <time_frame>Cycle 1: Days 1 and 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Parameter: Time to Reach the Maximum Observed Plasma Concentration (Tmax) for Onvansertib</measure>
    <time_frame>Cycle 1: Days 1 and 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Parameter: Area Under the Curve Over the First 24 Hours AUC(0-24) for Onvansertib</measure>
    <time_frame>Cycle 1: Days 1 and 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Parameter: Plasma Terminal Elimination Half-life (t1/2) for Onvansertib</measure>
    <time_frame>Cycle 1: Days 1 and 5</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <arm_group>
    <arm_group_label>Phase 1b: Onvansertib + low-dose cytarabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Onvansertib, administered in escalating doses orally Day 1 through Day 5 every 28 days (1 cycle) in combination with cytarabine, which will be administered in all cohorts as 20 mg/m^2 subcutaneously, once daily on Day 1 through Day 10 every 28 days (1 cycle). Onvansertib administration, in combination with cytarabine, will be initiated at a starting dose of 12 mg/m^2 orally, daily for 5 days. Onvansertib dose will be escalated in successive cohorts until the recommended phase 2 dose is achieved.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 1b: Onvansertib + decitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Onvansertib will be administered in escalating doses orally, Day 1 through Day 5 every 28 days (1 cycle) in combination with decitabine, administered consistently in all cohorts as 20 mg/m^2 intravenously over 1 hour on Day 1 through Day 5 every 28 days (1 cycle). Onvansertib administration, in combination with decitabine, will be initiated at a starting dose of 12 mg/m^2 orally, daily for 5 days (Day 1 through Day 5). Onvansertib dose will be escalated in successive cohorts until the recommended phase 2 dose is achieved.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2: Onvansertib + decitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Onvansertib recommended phase 2 dose, orally Day 1 through Day 5 every 28 days (1 cycle) and decitabine, administered consistently as 20 mg/m^2 intravenously over 1 hour on Day 1 through Day 5 every 28 days (1 cycle), with treatment modifications or delays based on return of hematopoietic function to baseline or Grade ≤1 toxicity for optimal subject management.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Onvansertib</intervention_name>
    <description>Onvansertib orally</description>
    <arm_group_label>Phase 1b: Onvansertib + decitabine</arm_group_label>
    <arm_group_label>Phase 1b: Onvansertib + low-dose cytarabine</arm_group_label>
    <arm_group_label>Phase 2: Onvansertib + decitabine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cytarabine</intervention_name>
    <description>subcutaneously</description>
    <arm_group_label>Phase 1b: Onvansertib + low-dose cytarabine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Decitabine</intervention_name>
    <description>intravenously</description>
    <arm_group_label>Phase 1b: Onvansertib + decitabine</arm_group_label>
    <arm_group_label>Phase 2: Onvansertib + decitabine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Disease Status and Prior Therapy:&#xD;
&#xD;
               1. Histologically confirmed AML with &gt;20% blasts&#xD;
&#xD;
               2. Phase 1b: Participants with AML who are refractory to or have relapsed after&#xD;
                  initial treatment for their disease, with no more than three prior lines of&#xD;
                  therapy. Participants who have received prior treatment with cytarabine or&#xD;
                  decitabine are not excluded.&#xD;
&#xD;
               3. Phase 2:&#xD;
&#xD;
             i. Participants with AML who are refractory to, or have relapsed after, initial&#xD;
             treatment for their disease, with no more than one prior line of therapy, and are&#xD;
             judged not to be candidates for re-induction therapy that includes hematopoietic cell&#xD;
             transplantation. Participants who have received prior cytarabine or decitabine are not&#xD;
             excluded.&#xD;
&#xD;
             OR&#xD;
&#xD;
             ii. Participants with newly diagnosed, untreated AML ineligible for, or who have&#xD;
             refused, standard intensive induction therapy&#xD;
&#xD;
          2. Age ≥18 years&#xD;
&#xD;
          3. ECOG performance status ≤2&#xD;
&#xD;
          4. Participants must be willing and able to review, understand, and provide written&#xD;
             consent before starting any study-specific procedures or therapy.&#xD;
&#xD;
          5. All men and women must agree to practice effective contraception during the entire&#xD;
             study period and after discontinuing study drug, unless documentation of infertility&#xD;
             exists&#xD;
&#xD;
               1. Sexually active, fertile women must use two effective forms of contraception&#xD;
                  (abstinence, intrauterine device, oral contraceptive, or double barrier device)&#xD;
                  from the time of informed consent and until at least 6 months after discontinuing&#xD;
                  study drug&#xD;
&#xD;
               2. Sexually active men and their sexual partners must use effective contraceptive&#xD;
                  methods from the time of participant informed consent and until at least 3 months&#xD;
                  after discontinuing study drug&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Treatment-related AML or acute promyelocytic leukemia (APL)&#xD;
&#xD;
          2. Active malignancies within 12 months with the exception of those with a negligible&#xD;
             risk of metastasis or death&#xD;
&#xD;
          3. Clinical evidence of active central nervous system leukemia at the time of screening&#xD;
&#xD;
          4. Alanine aminotransferase and/or aspartate aminotransferase ≥2.5 x upper limit of&#xD;
             normal (ULN)&#xD;
&#xD;
          5. Total bilirubin &gt; 2.0 mg/dL (or &gt; 3.0 mg/dL in participants with documented Gilbert&#xD;
             syndrome)&#xD;
&#xD;
          6. Serum creatinine ≥2.0 mg/dL&#xD;
&#xD;
          7. New York Heart Association Class III or IV heart disease, active ischemia or any other&#xD;
             uncontrolled cardiac condition, or hypertensive or metabolic condition&#xD;
&#xD;
          8. Myocardial infarction in the previous 12 weeks (from the start of treatment)&#xD;
&#xD;
          9. Resting left ventricular ejection fraction &lt;50% at the time of screening&#xD;
&#xD;
         10. QT (Interval from the beginning of the QRS complex to the end of the T wave on an&#xD;
             electrocardiogram) interval with Fridericia's correction [QTcF] &gt;450 milliseconds. The&#xD;
             QTcF should be calculated as the arithmetic mean of the QTcF on triplicate ECGs. In&#xD;
             the case of potentially correctible causes of QT prolongation (e.g., medications,&#xD;
             hypokalemia), the triplicate ECG may be repeated once during screening and that result&#xD;
             may be used to determine eligibility.&#xD;
&#xD;
         11. Active and uncontrolled disease (other than AML) or infection as judged by the&#xD;
             treating physician&#xD;
&#xD;
         12. Treatment with systemic therapy for the primary disease within 14 days (except for&#xD;
             hydroxyurea or isolated doses of cytarabine or decitabine for white blood cell&#xD;
             control)&#xD;
&#xD;
         13. Grade 2 or greater toxicities from prior therapy, except for Grade 2 toxicities that&#xD;
             are not expected to resolve and that in the judgment of the Investigator do not pose a&#xD;
             significant safety risk to subject participation.&#xD;
&#xD;
         14. Participants with any other medical condition, including mental illness or substance&#xD;
             abuse, deemed by the Investigator to be likely to interfere with the participant's&#xD;
             ability to sign the informed consent form or his/her ability to cooperate and&#xD;
             participate in the study, or to interfere with the interpretation of the results.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</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 Kansas Cancer Center</name>
      <address>
        <city>Westwood</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allina Health Virginia Piper Cancer Institute</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Roswell Park Cancer Institute</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Specialists - Fairfax Office</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Cancer Care Alliance</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <results_first_submitted>November 11, 2022</results_first_submitted>
  <results_first_submitted_qc>January 31, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 27, 2023</results_first_posted>
  <last_update_submitted>January 31, 2023</last_update_submitted>
  <last_update_submitted_qc>January 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PLK1</keyword>
  <keyword>PLK Inhibitor</keyword>
  <keyword>Onvansertib</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>Decitabine</mesh_term>
    <mesh_term>Onvansertib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 7, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT03303339/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 22, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT03303339/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>72 participants were enrolled across 8 sites in the United States.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to Day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.</description>
        </group>
        <group group_id="P2">
          <title>Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to Day 10 of each cycle, in order to determine the RP2D of onvansertib.</description>
        </group>
        <group group_id="P3">
          <title>Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.</description>
        </group>
        <group group_id="P4">
          <title>Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib</description>
        </group>
        <group group_id="P5">
          <title>Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to Day 10 of each cycle, in order to determine the RP2D of onvansertib.</description>
        </group>
        <group group_id="P6">
          <title>Phase 1b: Onvansertib 12 mg/m^2 + Decitabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.</description>
        </group>
        <group group_id="P7">
          <title>Phase 1b: Onvansertib 18 mg/m^2 + Decitabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.</description>
        </group>
        <group group_id="P8">
          <title>Phase 1b: Onvansertib 27 mg/m^2 + Decitabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.</description>
        </group>
        <group group_id="P9">
          <title>Phase 1b: Onvansertib 40 mg/m^2 + Decitabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.</description>
        </group>
        <group group_id="P10">
          <title>Phase 1b: Onvansertib 60 mg/m^2 + Decitabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.</description>
        </group>
        <group group_id="P11">
          <title>Phase 1b: Onvansertib 90 mg/m^2 + Decitabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.</description>
        </group>
        <group group_id="P12">
          <title>Phase 2: Onvansertib 60 mg/m^2 + Decitabine</title>
          <description>Participants were administered onvansertib at the RP2D on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="4"/>
                <participants group_id="P7" count="3"/>
                <participants group_id="P8" count="3"/>
                <participants group_id="P9" count="4"/>
                <participants group_id="P10" count="3"/>
                <participants group_id="P11" count="6"/>
                <participants group_id="P12" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="3"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="4"/>
                <participants group_id="P10" count="3"/>
                <participants group_id="P11" count="5"/>
                <participants group_id="P12" count="28"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="3"/>
                <participants group_id="P10" count="3"/>
                <participants group_id="P11" count="4"/>
                <participants group_id="P12" count="24"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Safety/Non-compliance</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to Day 10 of each cycle, in order to determine the RP2D of onvansertib.</description>
        </group>
        <group group_id="B2">
          <title>Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to Day 10 of each cycle, in order to determine the RP2D of onvansertib.</description>
        </group>
        <group group_id="B3">
          <title>Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to Day 10 of each cycle, in order to determine the RP2D of onvansertib.</description>
        </group>
        <group group_id="B4">
          <title>Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to Day 10 of each cycle, in order to determine the RP2D of onvansertib.</description>
        </group>
        <group group_id="B5">
          <title>Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to Day 10 of each cycle, in order to determine the RP2D of onvansertib.</description>
        </group>
        <group group_id="B6">
          <title>Phase 1b: Onvansertib 12 mg/m^2 + Decitabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib</description>
        </group>
        <group group_id="B7">
          <title>Phase 1b: Onvansertib 18 mg/m^2 + Decitabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib</description>
        </group>
        <group group_id="B8">
          <title>Phase 1b: Onvansertib 27 mg/m^2 + Decitabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib</description>
        </group>
        <group group_id="B9">
          <title>Phase 1b: Onvansertib 40 mg/m^2 + Decitabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib</description>
        </group>
        <group group_id="B10">
          <title>Phase 1b: Onvansertib 60 mg/m^2 + Decitabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib</description>
        </group>
        <group group_id="B11">
          <title>Phase 1b: Onvansertib 90 mg/m^2 + Decitabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib</description>
        </group>
        <group group_id="B12">
          <title>Phase 2: Onvansertib 60 mg/m^2 + Decitabine</title>
          <description>Participants were administered onvansertib at the RP2D on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle.</description>
        </group>
        <group group_id="B13">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="3"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="3"/>
            <count group_id="B4" value="3"/>
            <count group_id="B5" value="5"/>
            <count group_id="B6" value="4"/>
            <count group_id="B7" value="3"/>
            <count group_id="B8" value="3"/>
            <count group_id="B9" value="4"/>
            <count group_id="B10" value="3"/>
            <count group_id="B11" value="6"/>
            <count group_id="B12" value="32"/>
            <count group_id="B13" value="72"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="2"/>
                    <measurement group_id="B11" value="2"/>
                    <measurement group_id="B12" value="4"/>
                    <measurement group_id="B13" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="3"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="4"/>
                    <measurement group_id="B12" value="28"/>
                    <measurement group_id="B13" value="54"/>
                  </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="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="3"/>
                    <measurement group_id="B12" value="13"/>
                    <measurement group_id="B13" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="3"/>
                    <measurement group_id="B10" value="2"/>
                    <measurement group_id="B11" value="3"/>
                    <measurement group_id="B12" value="19"/>
                    <measurement group_id="B13" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="1"/>
                    <measurement group_id="B13" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="4"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="6"/>
                    <measurement group_id="B12" value="30"/>
                    <measurement group_id="B13" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="2"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="1"/>
                    <measurement group_id="B13" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="1"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="3"/>
                    <measurement group_id="B13" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="4"/>
                    <measurement group_id="B10" value="2"/>
                    <measurement group_id="B11" value="5"/>
                    <measurement group_id="B12" value="29"/>
                    <measurement group_id="B13" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Experienced Dose Limiting Toxicities (DLT)</title>
        <description>Dose-limiting toxicities were defined as events related to onvansertib that were considered an adverse reaction or suspected adverse reaction during the first cycle of therapy and that fulfilled one of the following: Hematologic (persistent pancytopenia resistant to current standards of care that continues for ≥42 days and is not related to leukemic infiltration or another cause unrelated to study therapy) or Non-Hematologic (any Grade 3 abnormalities that persist &gt;7 days without decreasing in severity despite standards of care, are clinically significant, or that are Grade 4 and symptomatic).</description>
        <time_frame>Up to Day 28 of Cycle 1</time_frame>
        <population>The safety analysis set was comprised of all subjects who received at least one dose of onvansertib.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.</description>
          </group>
          <group group_id="O5">
            <title>Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.</description>
          </group>
          <group group_id="O6">
            <title>Phase 1b: Onvansertib 12 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.</description>
          </group>
          <group group_id="O7">
            <title>Phase 1b: Onvansertib 18 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.</description>
          </group>
          <group group_id="O8">
            <title>Phase 1b: Onvansertib 27 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.</description>
          </group>
          <group group_id="O9">
            <title>Phase 1b: Onvansertib 40 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.</description>
          </group>
          <group group_id="O10">
            <title>Phase 1b: Onvansertib 60 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.</description>
          </group>
          <group group_id="O11">
            <title>Phase 1b: Onvansertib 90 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced Dose Limiting Toxicities (DLT)</title>
          <description>Dose-limiting toxicities were defined as events related to onvansertib that were considered an adverse reaction or suspected adverse reaction during the first cycle of therapy and that fulfilled one of the following: Hematologic (persistent pancytopenia resistant to current standards of care that continues for ≥42 days and is not related to leukemic infiltration or another cause unrelated to study therapy) or Non-Hematologic (any Grade 3 abnormalities that persist &gt;7 days without decreasing in severity despite standards of care, are clinically significant, or that are Grade 4 and symptomatic).</description>
          <population>The safety analysis set was comprised of all subjects who received at least one dose of onvansertib.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="5"/>
                <count group_id="O6" value="4"/>
                <count group_id="O7" value="3"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="4"/>
                <count group_id="O10" value="3"/>
                <count group_id="O11" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
              <group_id>O8</group_id>
              <group_id>O9</group_id>
              <group_id>O10</group_id>
              <group_id>O11</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Maximum Tolerated Dose</param_type>
            <param_value>60</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status</title>
        <description>ECOG performance status was determined using 6-point scale from 0-5, with 0 meaning a participant was fully active/able to carry on all pre-disease activities without restriction and 5 meaning the participant was deceased.</description>
        <time_frame>Baseline and end of study (approximately up to up to 27 months)</time_frame>
        <population>Per SAP It was pre-planned to report this data by treatment type instead of by dose.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: Onvansertib + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of Onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of Onvansertib.</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: Onvansertib + Decitabine</title>
            <description>Participants were administered escalating doses of Onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of Onvansertib.</description>
          </group>
          <group group_id="O3">
            <title>Phase 2: Onvansertib + Decitabine</title>
            <description>Participants were administered Onvansertib at the recommended phase 2 dose (RP2D) on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status</title>
          <description>ECOG performance status was determined using 6-point scale from 0-5, with 0 meaning a participant was fully active/able to carry on all pre-disease activities without restriction and 5 meaning the participant was deceased.</description>
          <population>Per SAP It was pre-planned to report this data by treatment type instead of by dose.</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="17"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Phase 2: Number of Participants Who Achieved a Complete Response (CR)</title>
        <description>Complete Response also includes Complete Response with Incomplete Blood Count Recovery (CRi). Complete response is defined by the following criteria:&#xD;
Morphologic leukemia-free state plus:&#xD;
Subject is independent of transfusions&#xD;
Absolute neutrophil count of &gt;1000/mm3&#xD;
Platelets of ≥100,000/mm3&#xD;
Complete response with incomplete blood count recovery meets all criteria for CR except for either neutropenia (ANC &lt;1000/mm3) or thrombocytopenia (&lt;100,000/mm3) but must include transfusion independence.</description>
        <time_frame>Up to 27 months</time_frame>
        <population>Only participants in Phase 2 were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 2: Onvansertib + Decitabine</title>
            <description>Participants were administered Onvansertib at the recommended phase 2 dose (RP2D) on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 2: Number of Participants Who Achieved a Complete Response (CR)</title>
          <description>Complete Response also includes Complete Response with Incomplete Blood Count Recovery (CRi). Complete response is defined by the following criteria:&#xD;
Morphologic leukemia-free state plus:&#xD;
Subject is independent of transfusions&#xD;
Absolute neutrophil count of &gt;1000/mm3&#xD;
Platelets of ≥100,000/mm3&#xD;
Complete response with incomplete blood count recovery meets all criteria for CR except for either neutropenia (ANC &lt;1000/mm3) or thrombocytopenia (&lt;100,000/mm3) but must include transfusion independence.</description>
          <population>Only participants in Phase 2 were included in this analysis.</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="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Adverse Events (AEs)</title>
        <description>Any clinically significant change in electrocardiogram (ECG), physical examination findings, body weight, vital signs, and laboratory parameters were recorded as Adverse Events.</description>
        <time_frame>Baseline up to 30 days after last dose of study drug (up to 27 months)</time_frame>
        <population>The safety analysis set was comprised of all subjects who received at least one dose of onvansertib.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O5">
            <title>Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O6">
            <title>Phase 1b: Onvansertib 12 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O7">
            <title>Phase 1b: Onvansertib 18 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O8">
            <title>Phase 1b: Onvansertib 27 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O9">
            <title>Phase 1b: Onvansertib 40 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O10">
            <title>Phase 1b: Onvansertib 60 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O11">
            <title>Phase 1b: Onvansertib 90 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O12">
            <title>Phase 2: Onvansertib 60 mg/m^2 + Decitabine</title>
            <description>Participants were administered onvansertib on Day 1 through Day 5 every 21 to 28 days, in combination with decitabine, administered consistently as 20 mg/m^2 over 1 hour on Day 1 through Day 5 every 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs)</title>
          <description>Any clinically significant change in electrocardiogram (ECG), physical examination findings, body weight, vital signs, and laboratory parameters were recorded as Adverse Events.</description>
          <population>The safety analysis set was comprised of all subjects who received at least one dose of onvansertib.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="5"/>
                <count group_id="O6" value="4"/>
                <count group_id="O7" value="3"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="4"/>
                <count group_id="O10" value="3"/>
                <count group_id="O11" value="6"/>
                <count group_id="O12" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="3"/>
                    <measurement group_id="O8" value="3"/>
                    <measurement group_id="O9" value="4"/>
                    <measurement group_id="O10" value="3"/>
                    <measurement group_id="O11" value="6"/>
                    <measurement group_id="O12" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Serious Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="3"/>
                    <measurement group_id="O8" value="3"/>
                    <measurement group_id="O9" value="4"/>
                    <measurement group_id="O10" value="2"/>
                    <measurement group_id="O11" value="5"/>
                    <measurement group_id="O12" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Treatment-Related Serious Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="1"/>
                    <measurement group_id="O11" value="3"/>
                    <measurement group_id="O12" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 2: Number of Participants Who Achieved a Morphologic Leukemia-free (MLF) State</title>
        <description>Defined as bone marrow (BM) &lt;5% blasts in an aspirate with spicules and no blasts with Auer rods or persistence of extramedullary disease.</description>
        <time_frame>Up to 27 months</time_frame>
        <population>Only participants in Phase 2 were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 2: Onvansertib + Decitabine</title>
            <description>Onvansertib recommended phase 2 dose, orally Day 1 through Day 5 every 28 days (1 cycle) and decitabine, administered consistently as 20 mg/m^2 intravenously over 1 hour on Day 1 through Day 5 every 28 days (1 cycle), with treatment modifications or delays based on return of hematopoietic function to baseline or Grade ≤1 toxicity for optimal subject management.&#xD;
Onvansertib: Onvansertib orally&#xD;
Decitabine: intravenously</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 2: Number of Participants Who Achieved a Morphologic Leukemia-free (MLF) State</title>
          <description>Defined as bone marrow (BM) &lt;5% blasts in an aspirate with spicules and no blasts with Auer rods or persistence of extramedullary disease.</description>
          <population>Only participants in Phase 2 were included in this analysis.</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="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 2: Number of Participants With Partial Response (PR)</title>
        <description>PR criteria includes all of the hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate and a normalization of blood counts.</description>
        <time_frame>Up to 27 months</time_frame>
        <population>Only participants included in Phase 2 were used in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 2: Onvansertib + Decitabine</title>
            <description>Participants were administered Onvansertib at the recommended phase 2 dose (RP2D) on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 2: Number of Participants With Partial Response (PR)</title>
          <description>PR criteria includes all of the hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate and a normalization of blood counts.</description>
          <population>Only participants included in Phase 2 were used in this analysis.</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="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 2: Duration of Response (DOR)</title>
        <description>Duration of Response (DOR) is the time (in months) from the first response of CR, CRi or PR until recurrence of or progression of disease (or death). MLF State is also included as a response when calculating DOR. Responding subjects without death or progression will be censored at the date of their last evaluable disease assessment.</description>
        <time_frame>Up to 27 months</time_frame>
        <population>Only participants in Phase 2 were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 2: Onvansertib + Decitabine</title>
            <description>Participants were administered Onvansertib at the recommended phase 2 dose (RP2D) on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 2: Duration of Response (DOR)</title>
          <description>Duration of Response (DOR) is the time (in months) from the first response of CR, CRi or PR until recurrence of or progression of disease (or death). MLF State is also included as a response when calculating DOR. Responding subjects without death or progression will be censored at the date of their last evaluable disease assessment.</description>
          <population>Only participants in Phase 2 were included in this analysis.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" lower_limit="0.0" upper_limit="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 2: Event-free Survival (EFS)</title>
        <description>EFS is defined as the time from enrollment until disease progression or death from any cause and reported as the proportion of participants event free at 12 months.</description>
        <time_frame>12 Months</time_frame>
        <population>Only participants in Phase 2 were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 2: Onvansertib + Decitabine</title>
            <description>Participants were administered Onvansertib at the recommended phase 2 dose (RP2D) on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 2: Event-free Survival (EFS)</title>
          <description>EFS is defined as the time from enrollment until disease progression or death from any cause and reported as the proportion of participants event free at 12 months.</description>
          <population>Only participants in Phase 2 were included in this analysis.</population>
          <units>Proportion of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="0.0" upper_limit="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 2: Overall Survival (OS)</title>
        <description>OS is defined as the time from enrollment until death from any cause and reported as the proportion of participants alive at 12 months.</description>
        <time_frame>12 Months</time_frame>
        <population>Only participants included in Phase 2 were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 2: Onvansertib + Decitabine</title>
            <description>Participants were administered Onvansertib at the recommended phase 2 dose (RP2D) on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 2: Overall Survival (OS)</title>
          <description>OS is defined as the time from enrollment until death from any cause and reported as the proportion of participants alive at 12 months.</description>
          <population>Only participants included in Phase 2 were included in this analysis.</population>
          <units>Proportion of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="0.1" upper_limit="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetic Parameter: Maximum Observed Plasma Concentration (Cmax) for Onvansertib</title>
        <time_frame>Cycle 1: Days 1 and 5</time_frame>
        <population>The PK analysis set consisted of all subjects in the safety analysis set who received onvansertib and had adequate plasma onvansertib concentration data as determined by the PK scientist.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O5">
            <title>Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O6">
            <title>Phase 1b: Onvansertib 12 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O7">
            <title>Phase 1b: Onvansertib 18 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O8">
            <title>Phase 1b: Onvansertib 27 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O9">
            <title>Phase 1b: Onvansertib 40 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O10">
            <title>Phase 1b: Onvansertib 60 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O11">
            <title>Phase 1b: Onvansertib 90 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O12">
            <title>Phase 2: Onvansertib 60 mg/m^2 + Decitabine</title>
            <description>Participants were administered onvansertib at the RP2D on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Parameter: Maximum Observed Plasma Concentration (Cmax) for Onvansertib</title>
          <population>The PK analysis set consisted of all subjects in the safety analysis set who received onvansertib and had adequate plasma onvansertib concentration data as determined by the PK scientist.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="5"/>
                <count group_id="O6" value="4"/>
                <count group_id="O7" value="3"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="4"/>
                <count group_id="O10" value="3"/>
                <count group_id="O11" value="6"/>
                <count group_id="O12" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1 Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.57" spread="5.66"/>
                    <measurement group_id="O2" value="69.56" spread="28.73"/>
                    <measurement group_id="O3" value="251.16" spread="85.37"/>
                    <measurement group_id="O4" value="256.11" spread="24.96"/>
                    <measurement group_id="O5" value="626.18" spread="61.37"/>
                    <measurement group_id="O6" value="80.15" spread="21.33"/>
                    <measurement group_id="O7" value="129.18" spread="93.78"/>
                    <measurement group_id="O8" value="309.86" spread="72.47"/>
                    <measurement group_id="O9" value="410.42" spread="26.38"/>
                    <measurement group_id="O10" value="724.76" spread="57.33"/>
                    <measurement group_id="O11" value="737.21" spread="43.06"/>
                    <measurement group_id="O12" value="515.63" spread="43.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 1 Day 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="139.22" spread="55.12"/>
                    <measurement group_id="O2" value="103.27" spread="43.01"/>
                    <measurement group_id="O3" value="298.63" spread="66.58"/>
                    <measurement group_id="O4" value="339.52" spread="31.25"/>
                    <measurement group_id="O5" value="857.29" spread="38.54"/>
                    <measurement group_id="O6" value="146.10" spread="56.75"/>
                    <measurement group_id="O7" value="197.67" spread="85.14"/>
                    <measurement group_id="O8" value="398.38" spread="32.95"/>
                    <measurement group_id="O9" value="496.24" spread="52.72"/>
                    <measurement group_id="O10" value="955.59" spread="54.78"/>
                    <measurement group_id="O11" value="1137.16" spread="61.56"/>
                    <measurement group_id="O12" value="861.86" spread="46.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetic Parameter: Time to Reach the Maximum Observed Plasma Concentration (Tmax) for Onvansertib</title>
        <time_frame>Cycle 1: Days 1 and 5</time_frame>
        <population>The PK analysis set consisted of all subjects in the safety analysis set who received onvansertib and had adequate plasma onvansertib concentration data as determined by the PK scientist.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O5">
            <title>Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O6">
            <title>Phase 1b: Onvansertib 12 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O7">
            <title>Phase 1b: Onvansertib 18 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O8">
            <title>Phase 1b: Onvansertib 27 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O9">
            <title>Phase 1b: Onvansertib 40 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O10">
            <title>Phase 1b: Onvansertib 60 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O11">
            <title>Phase 1b: Onvansertib 90 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O12">
            <title>Phase 2: Onvansertib 60 mg/m^2 + Decitabine</title>
            <description>Participants were administered onvansertib at the RP2D on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Parameter: Time to Reach the Maximum Observed Plasma Concentration (Tmax) for Onvansertib</title>
          <population>The PK analysis set consisted of all subjects in the safety analysis set who received onvansertib and had adequate plasma onvansertib concentration data as determined by the PK scientist.</population>
          <units>Hours</units>
          <param>Geometric Least Squares Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="5"/>
                <count group_id="O6" value="4"/>
                <count group_id="O7" value="3"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="4"/>
                <count group_id="O10" value="3"/>
                <count group_id="O11" value="6"/>
                <count group_id="O12" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1 Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.961" spread="81.664"/>
                    <measurement group_id="O2" value="2.548" spread="96.282"/>
                    <measurement group_id="O3" value="2.301" spread="84.217"/>
                    <measurement group_id="O4" value="1.384" spread="103.829"/>
                    <measurement group_id="O5" value="2.071" spread="39.570"/>
                    <measurement group_id="O6" value="3.102" spread="31.792"/>
                    <measurement group_id="O7" value="2.365" spread="78.396"/>
                    <measurement group_id="O8" value="1.288" spread="41.249"/>
                    <measurement group_id="O9" value="1.373" spread="49.676"/>
                    <measurement group_id="O10" value="2.893" spread="135.893"/>
                    <measurement group_id="O11" value="2.435" spread="53.682"/>
                    <measurement group_id="O12" value="2.725" spread="69.661"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 1 Day 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.844" spread="62.646"/>
                    <measurement group_id="O2" value="2.892" spread="37.244"/>
                    <measurement group_id="O3" value="2.267" spread="82.486"/>
                    <measurement group_id="O4" value="1.474" spread="67.999"/>
                    <measurement group_id="O5" value="2.148" spread="55.159"/>
                    <measurement group_id="O6" value="2.438" spread="24.524"/>
                    <measurement group_id="O7" value="1.583" spread="96.305"/>
                    <measurement group_id="O8" value="3.145" spread="33.877"/>
                    <measurement group_id="O9" value="3.161" spread="41.350"/>
                    <measurement group_id="O10" value="3.161" spread="41.350"/>
                    <measurement group_id="O11" value="3.189" spread="29.775"/>
                    <measurement group_id="O12" value="2.665" spread="51.333"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetic Parameter: Area Under the Curve Over the First 24 Hours AUC(0-24) for Onvansertib</title>
        <time_frame>Cycle 1: Days 1 and 5</time_frame>
        <population>The PK analysis set consisted of all subjects in the safety analysis set who received onvansertib and had adequate plasma onvansertib concentration data as determined by the PK scientist.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O5">
            <title>Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O6">
            <title>Phase 1b: Onvansertib 12 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O7">
            <title>Phase 1b: Onvansertib 18 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O8">
            <title>Phase 1b: Onvansertib 27 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O9">
            <title>Phase 1b: Onvansertib 40 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O10">
            <title>Phase 1b: Onvansertib 60 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O11">
            <title>Phase 1b: Onvansertib 90 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O12">
            <title>Phase 2: Onvansertib 60 mg/m^2 + Decitabine</title>
            <description>Participants were administered onvansertib at the RP2D on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Parameter: Area Under the Curve Over the First 24 Hours AUC(0-24) for Onvansertib</title>
          <population>The PK analysis set consisted of all subjects in the safety analysis set who received onvansertib and had adequate plasma onvansertib concentration data as determined by the PK scientist.</population>
          <units>h*ng/mL</units>
          <param>Geometric Least Squares Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="5"/>
                <count group_id="O6" value="4"/>
                <count group_id="O7" value="3"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="4"/>
                <count group_id="O10" value="3"/>
                <count group_id="O11" value="6"/>
                <count group_id="O12" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1 Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1197.93" spread="23.42"/>
                    <measurement group_id="O2" value="772.68" spread="26.21"/>
                    <measurement group_id="O3" value="2534.22" spread="31.05"/>
                    <measurement group_id="O4" value="2761.11" spread="36.97"/>
                    <measurement group_id="O5" value="5386.69" spread="59.16"/>
                    <measurement group_id="O6" value="1099.43" spread="29.81"/>
                    <measurement group_id="O7" value="2789.81" spread="25.30"/>
                    <measurement group_id="O8" value="3257.57" spread="53.53"/>
                    <measurement group_id="O9" value="4084.18" spread="27.94"/>
                    <measurement group_id="O10" value="9599.19" spread="25.01"/>
                    <measurement group_id="O11" value="9087.77" spread="57.43"/>
                    <measurement group_id="O12" value="6280.28" spread="46.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 1 Day 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1868.69" spread="70.99"/>
                    <measurement group_id="O2" value="3626.44" spread="5.33"/>
                    <measurement group_id="O3" value="5343.01" spread="2.11"/>
                    <measurement group_id="O4" value="7415.04" spread="64.35"/>
                    <measurement group_id="O5" value="19470.17" spread="17.10"/>
                    <measurement group_id="O6" value="1868.69" spread="70.99"/>
                    <measurement group_id="O7" value="3626.44" spread="5.33"/>
                    <measurement group_id="O8" value="5343.01" spread="2.11"/>
                    <measurement group_id="O9" value="7415.04" spread="64.35"/>
                    <measurement group_id="O10" value="19470.17" spread="17.10"/>
                    <measurement group_id="O11" value="12981.17" spread="56.18"/>
                    <measurement group_id="O12" value="11767.29" spread="39.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetic Parameter: Plasma Terminal Elimination Half-life (t1/2) for Onvansertib</title>
        <time_frame>Cycle 1: Days 1 and 5</time_frame>
        <population>The PK analysis set consisted of all subjects in the safety analysis set who received onvansertib and had adequate plasma onvansertib concentration data as determined by the PK scientist.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.</description>
          </group>
          <group group_id="O5">
            <title>Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O6">
            <title>Phase 1b: Onvansertib 12 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O7">
            <title>Phase 1b: Onvansertib 18 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O8">
            <title>Phase 1b: Onvansertib 27 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O9">
            <title>Phase 1b: Onvansertib 40 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O10">
            <title>Phase 1b: Onvansertib 60 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O11">
            <title>Phase 1b: Onvansertib 90 mg/m^2 + Decitabine</title>
            <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.</description>
          </group>
          <group group_id="O12">
            <title>Phase 2: Onvansertib 60 mg/m^2 + Decitabine</title>
            <description>Participants were administered onvansertib at the RP2D on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Parameter: Plasma Terminal Elimination Half-life (t1/2) for Onvansertib</title>
          <population>The PK analysis set consisted of all subjects in the safety analysis set who received onvansertib and had adequate plasma onvansertib concentration data as determined by the PK scientist.</population>
          <units>Hours</units>
          <param>Geometric Least Squares Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="5"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="2"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="4"/>
                <count group_id="O10" value="2"/>
                <count group_id="O11" value="3"/>
                <count group_id="O12" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="3"/>
                    <count group_id="O5" value="5"/>
                    <count group_id="O6" value="2"/>
                    <count group_id="O7" value="2"/>
                    <count group_id="O8" value="3"/>
                    <count group_id="O9" value="4"/>
                    <count group_id="O10" value="2"/>
                    <count group_id="O11" value="3"/>
                    <count group_id="O12" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.294" spread="11.098"/>
                    <measurement group_id="O2" value="7.993" spread="NA">Not calculable due to only 1 participant being analyzed.</measurement>
                    <measurement group_id="O3" value="12.197" spread="71.258"/>
                    <measurement group_id="O4" value="11.747" spread="63.901"/>
                    <measurement group_id="O5" value="7.309" spread="99.539"/>
                    <measurement group_id="O6" value="16.960" spread="54.430"/>
                    <measurement group_id="O7" value="13.795" spread="28.866"/>
                    <measurement group_id="O8" value="9.394" spread="20.598"/>
                    <measurement group_id="O9" value="11.389" spread="39.530"/>
                    <measurement group_id="O10" value="12.917" spread="41.715"/>
                    <measurement group_id="O11" value="12.633" spread="50.655"/>
                    <measurement group_id="O12" value="11.904" spread="29.602"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 1 Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="3"/>
                    <count group_id="O5" value="5"/>
                    <count group_id="O6" value="2"/>
                    <count group_id="O7" value="2"/>
                    <count group_id="O8" value="3"/>
                    <count group_id="O9" value="4"/>
                    <count group_id="O10" value="1"/>
                    <count group_id="O11" value="3"/>
                    <count group_id="O12" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.413" spread="28.186"/>
                    <measurement group_id="O2" value="12.561" spread="38.983"/>
                    <measurement group_id="O3" value="12.246" spread="38.286"/>
                    <measurement group_id="O4" value="7.321" spread="8.094"/>
                    <measurement group_id="O5" value="14.484" spread="32.002"/>
                    <measurement group_id="O6" value="13.282" spread="39.361"/>
                    <measurement group_id="O7" value="9.082" spread="25.356"/>
                    <measurement group_id="O8" value="10.713" spread="23.782"/>
                    <measurement group_id="O9" value="16.337" spread="27.365"/>
                    <measurement group_id="O10" value="44.018" spread="NA">Not calculable due to only 1 participant being analyzed.</measurement>
                    <measurement group_id="O11" value="12.378" spread="10.948"/>
                    <measurement group_id="O12" value="14.060" spread="28.874"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>27 months</time_frame>
      <desc>Participants included in the Safety Analysis Set were included in this analysis.</desc>
      <group_list>
        <group group_id="E1">
          <title>Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.</description>
        </group>
        <group group_id="E2">
          <title>Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.</description>
        </group>
        <group group_id="E3">
          <title>Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.</description>
        </group>
        <group group_id="E4">
          <title>Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.</description>
        </group>
        <group group_id="E5">
          <title>Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.</description>
        </group>
        <group group_id="E6">
          <title>Phase 1b: Onvansertib 12 mg/m^2 + Decitabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.</description>
        </group>
        <group group_id="E7">
          <title>Phase 1b: Onvansertib 18 mg/m^2 + Decitabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.</description>
        </group>
        <group group_id="E8">
          <title>Phase 1b: Onvansertib 27 mg/m^2 + Decitabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.</description>
        </group>
        <group group_id="E9">
          <title>Phase 1b: Onvansertib 40 mg/m^2 + Decitabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.</description>
        </group>
        <group group_id="E10">
          <title>Phase 1b: Onvansertib 60 mg/m^2 + Decitabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.</description>
        </group>
        <group group_id="E11">
          <title>Phase 1b: Onvansertib 90 mg/m^2 + Decitabine</title>
          <description>Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.</description>
        </group>
        <group group_id="E12">
          <title>Phase 2: Onvansertib 60 mg/m^2 + Decitabine</title>
          <description>Participants were administered onvansertib at the recommended phase 2 dose (RP2D) on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (20.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E11" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="24" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E11" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="27" subjects_at_risk="32"/>
              </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" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E9" events="4" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="10" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E12" events="8" subjects_affected="8" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="3" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Mallory-Weiss syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Melaena</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Neutropenic colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Proctalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="1" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="4" subjects_affected="4" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="5" subjects_affected="4" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Escherichia bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Candida infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Granulicatella bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Kidney infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Klebsiella bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pneumonia fungal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Serratia bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Soft tissue infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Seroma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Transfusion reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Urine output decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Tumour lysis syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="6" subjects_affected="4" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pain in jaw</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </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" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="5" subjects_affected="5" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Leukaemic infiltration pulmonary</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Aphasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pharyngeal oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Lung consolidation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pulmonary mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Palmar-plantar erythodysaesthesia syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (20.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E11" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="32" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="3" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E11" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E12" events="7" subjects_affected="4" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E9" events="7" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="10" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E12" events="14" subjects_affected="12" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Disseminated intravascular coagulation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Otorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Photophobia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Visual acuity reduced</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Conjunctival haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E12" events="10" subjects_affected="9" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="6" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="5" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E12" events="9" subjects_affected="7" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="3" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E11" events="5" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E12" events="10" subjects_affected="9" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Gingival bleeding</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Haemorrhoidal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E11" events="5" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E12" events="3" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="3" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="3" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="3" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="3" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Odynophagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Proctalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="4" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E11" events="3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E12" events="8" subjects_affected="8" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="6" subjects_affected="6" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Face oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Face oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="4" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="5" subjects_affected="3" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E12" events="5" subjects_affected="4" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="4" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="6" subjects_affected="5" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Escherichia bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="3" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="3" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="4" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pneumonia fungal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="3" subjects_affected="3" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Seroma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Transfusion reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="4" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E11" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E12" events="9" subjects_affected="6" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="3" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="4" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E12" events="3" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="4" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Urine output decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="3" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Blood creatine increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="3" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Electrocardiogram QT prolonged</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="3" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Blood urea increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="3" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="3" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Tumour lysis syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E12" events="11" subjects_affected="10" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="6" subjects_affected="5" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="6" subjects_affected="5" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="3" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="6" subjects_affected="4" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="10" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="4" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="3" subjects_affected="2" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Muscle haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="6" subjects_affected="4" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pain in jaw</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </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" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="5" subjects_affected="5" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Leukaemic infiltration pulmonary</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="3" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="4" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="3" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Aphasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Sexual dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="4" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="6" subjects_affected="5" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="6" subjects_affected="5" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="3" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="9" subjects_affected="7" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Increased bronchial secretion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Laryngeal inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="3" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E12" events="3" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Orthopnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pharyngeal oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Stridor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="5" subjects_affected="4" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Lung consolidation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E11" events="4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E12" events="4" subjects_affected="4" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="6" subjects_affected="6" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Dermatitis bullous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Onychoclasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Petechiae</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="3" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Red man syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="7" subjects_affected="4" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="4" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E12" events="3" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Purpora</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Rash macular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E12" events="5" subjects_affected="4" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="4" subjects_affected="4" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </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 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>Nancy Sherman, Head of Clinical Operations</name_or_title>
      <organization>Cardiff Oncology</organization>
      <phone>858-952-7570</phone>
      <email>clinops@cardiffoncology.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/NCT03303339
org study id: TROV-052
secondary id: U1111-1201-6416
nct id: NCT03303339
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of the phase 1b/2 study is to determine whether Onvansertib given orally daily
      for 5 consecutive days every 28 days is safe and tolerable in adult patients who have
      relapsed/refractory Acute Myeloid Leukemia (AML), or are ineligible for intensive induction
      therapy, and to determine the maximum tolerated dose and recommended phase 2 dose of
      Onvansertib in combination with decitabine or Onvansertib in combination with low-dose
      cytarabine. In the phase 2 portion of the study, Onvansertib in combination with decitabine
      will be studied to provide further data on the safety profile of the combination and to
      preliminarily assess the activity of the chosen combination in patients with untreated AML
      who are not candidates for aggressive induction therapy, or who have received one prior
      treatment for their AML.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants Who Experienced Dose Limiting Toxicities (DLT)
time frame: Up to Day 28 of Cycle 1
description: Dose-limiting toxicities were defined as events related to onvansertib that were considered an adverse reaction or suspected adverse reaction during the first cycle of therapy and that fulfilled one of the following: Hematologic (persistent pancytopenia resistant to current standards of care that continues for ≥42 days and is not related to leukemic infiltration or another cause unrelated to study therapy) or Non-Hematologic (any Grade 3 abnormalities that persist >7 days without decreasing in severity despite standards of care, are clinically significant, or that are Grade 4 and symptomatic).
measure: Number of Participants With Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status
time frame: Baseline and end of study (approximately up to up to 27 months)
description: ECOG performance status was determined using 6-point scale from 0-5, with 0 meaning a participant was fully active/able to carry on all pre-disease activities without restriction and 5 meaning the participant was deceased.
measure: Phase 2: Number of Participants Who Achieved a Complete Response (CR)
time frame: Up to 27 months
description: Complete Response also includes Complete Response with Incomplete Blood Count Recovery (CRi). Complete response is defined by the following criteria:
Morphologic leukemia-free state plus:
Subject is independent of transfusions
Absolute neutrophil count of >1000/mm3
Platelets of ≥100,000/mm3
Complete response with incomplete blood count recovery meets all criteria for CR except for either neutropenia (ANC <1000/mm3) or thrombocytopenia (<100,000/mm3) but must include transfusion independence.
measure: Number of Participants With Adverse Events (AEs)
time frame: Baseline up to 30 days after last dose of study drug (up to 27 months)
description: Any clinically significant change in electrocardiogram (ECG), physical examination findings, body weight, vital signs, and laboratory parameters were recorded as Adverse Events.
measure: Phase 2: Number of Participants Who Achieved a Morphologic Leukemia-free (MLF) State
time frame: Up to 27 months
description: Defined as bone marrow (BM) <5% blasts in an aspirate with spicules and no blasts with Auer rods or persistence of extramedullary disease.
measure: Phase 2: Number of Participants With Partial Response (PR)
time frame: Up to 27 months
description: PR criteria includes all of the hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate and a normalization of blood counts.
measure: Phase 2: Duration of Response (DOR)
time frame: Up to 27 months
description: Duration of Response (DOR) is the time (in months) from the first response of CR, CRi or PR until recurrence of or progression of disease (or death). MLF State is also included as a response when calculating DOR. Responding subjects without death or progression will be censored at the date of their last evaluable disease assessment.
measure: Phase 2: Event-free Survival (EFS)
time frame: 12 Months
description: EFS is defined as the time from enrollment until disease progression or death from any cause and reported as the proportion of participants event free at 12 months.
measure: Phase 2: Overall Survival (OS)
time frame: 12 Months
description: OS is defined as the time from enrollment until death from any cause and reported as the proportion of participants alive at 12 months.
measure: Pharmacokinetic Parameter: Maximum Observed Plasma Concentration (Cmax) for Onvansertib
time frame: Cycle 1: Days 1 and 5
measure: Pharmacokinetic Parameter: Time to Reach the Maximum Observed Plasma Concentration (Tmax) for Onvansertib
time frame: Cycle 1: Days 1 and 5
measure: Pharmacokinetic Parameter: Area Under the Curve Over the First 24 Hours AUC(0-24) for Onvansertib
time frame: Cycle 1: Days 1 and 5
measure: Pharmacokinetic Parameter: Plasma Terminal Elimination Half-life (t1/2) for Onvansertib
time frame: Cycle 1: Days 1 and 5
arm group label: Phase 1b: Onvansertib + low-dose cytarabine
arm group type: Experimental
description: Onvansertib, administered in escalating doses orally Day 1 through Day 5 every 28 days (1 cycle) in combination with cytarabine, which will be administered in all cohorts as 20 mg/m^2 subcutaneously, once daily on Day 1 through Day 10 every 28 days (1 cycle). Onvansertib administration, in combination with cytarabine, will be initiated at a starting dose of 12 mg/m^2 orally, daily for 5 days. Onvansertib dose will be escalated in successive cohorts until the recommended phase 2 dose is achieved.
arm group label: Phase 1b: Onvansertib + decitabine
arm group type: Experimental
description: Onvansertib will be administered in escalating doses orally, Day 1 through Day 5 every 28 days (1 cycle) in combination with decitabine, administered consistently in all cohorts as 20 mg/m^2 intravenously over 1 hour on Day 1 through Day 5 every 28 days (1 cycle). Onvansertib administration, in combination with decitabine, will be initiated at a starting dose of 12 mg/m^2 orally, daily for 5 days (Day 1 through Day 5). Onvansertib dose will be escalated in successive cohorts until the recommended phase 2 dose is achieved.
arm group label: Phase 2: Onvansertib + decitabine
arm group type: Experimental
description: Onvansertib recommended phase 2 dose, orally Day 1 through Day 5 every 28 days (1 cycle) and decitabine, administered consistently as 20 mg/m^2 intravenously over 1 hour on Day 1 through Day 5 every 28 days (1 cycle), with treatment modifications or delays based on return of hematopoietic function to baseline or Grade ≤1 toxicity for optimal subject management.
intervention type: Drug
intervention name: Onvansertib
description: Onvansertib orally
arm group label: Phase 1b: Onvansertib + decitabine
arm group label: Phase 1b: Onvansertib + low-dose cytarabine
arm group label: Phase 2: Onvansertib + decitabine
intervention type: Drug
intervention name: Cytarabine
description: subcutaneously
arm group label: Phase 1b: Onvansertib + low-dose cytarabine
intervention type: Drug
intervention name: Decitabine
description: intravenously
arm group label: Phase 1b: Onvansertib + decitabine
arm group label: Phase 2: Onvansertib + decitabine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Cytarabine
mesh term: Decitabine
mesh term: Onvansertib
sharing ipd: Undecided
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 