<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/NCT01721876</url>
  </required_header>
  <id_info>
    <org_study_id>1230.14</org_study_id>
    <secondary_id>2012-002487-27</secondary_id>
    <nct_id>NCT01721876</nct_id>
  </id_info>
  <brief_title>Volasertib in Combination With Low-dose Cytarabine in Patients Aged 65 Years and Above With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy (POLO-AML-2)</brief_title>
  <official_title>A Phase III Randomised, Double-blind, Controlled, Parallel Group Study of Intravenous Volasertib in Combination With Subcutaneous Low-dose Cytarabine vs. Placebo + Low-dose Cytarabine in Patients &gt;=65 Years With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      To investigate the efficacy, safety, and pharmacokinetics of intravenous volasertib +&#xD;
      subcutaneous low dose cytarabine in patients &gt;= 65 years of age with previously untreated&#xD;
      acute myeloid leukaemia, ineligible for intensive remission induction therapy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 29, 2013</start_date>
  <completion_date type="Actual">May 28, 2021</completion_date>
  <primary_completion_date type="Actual">August 12, 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective Response (OR)</measure>
    <time_frame>Response assessment was performed at the end of every 2nd cycle, (i.e. at the end of Cycle 2, 4, 6, 8, etc., and at end of treatment), i.e. up to 52 months.</time_frame>
    <description>OR is the number of patients who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi), where OR was based on the best response attained during the treatment period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>From randomization until death due to any cause, up to 1557 days.</time_frame>
    <description>OS is the key secondary endpoint and was measured from the date of randomization until death from any cause. Patients who were lost to follow-up were censored on the last date they were known to be alive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event-free Survival (EFS)</measure>
    <time_frame>From randomization until disease progression or relapse or death from any cause, up to 1557 days.</time_frame>
    <description>EFS was measured from the date of randomisation to the date of progression or relapse, or death from any cause, whichever occurred first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse-free Survival (RFS)</measure>
    <time_frame>From randomization until disease progression or relapse or death from any cause, up to 1557 days.</time_frame>
    <description>RFS was defined only for patients who achieved best overall response of CR or CRi; it was measured from the date of achievement of a remission until the date of relapse or death from any cause. Patients not known to have relapsed or died at last follow-up were censored on the date they were last examined.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">666</enrollment>
  <condition>Leukemia, Myeloid, Acute</condition>
  <arm_group>
    <arm_group_label>Volasertib and Cytarabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo and Cytarabine</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo matching Volasertib</description>
    <arm_group_label>Placebo and Cytarabine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Volasertib</intervention_name>
    <description>Volasertib</description>
    <arm_group_label>Volasertib and Cytarabine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cytarabine</intervention_name>
    <description>Cytarabine</description>
    <arm_group_label>Placebo and Cytarabine</arm_group_label>
    <arm_group_label>Volasertib and Cytarabine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Age &gt;= 65years.&#xD;
&#xD;
          2. Cytologically/histologically confirmed acute myeloid leukaemia (AML) according to WHO&#xD;
             classification; (except for acute promyelocytic leukaemia (APL).&#xD;
&#xD;
          3. Previously untreated AML (except for hydroxyurea and/or corticosteroid therapy for no&#xD;
             more than 28 days (cumulative)). Previous therapy for Myelodysplastic Syndrome (MDS)&#xD;
             is allowed.&#xD;
&#xD;
          4. Investigator considers patient ineligible for intensive remission induction therapy&#xD;
             based on documented medical reasons (e.g. disease characteristics like AML genetics,&#xD;
             type of AML (de novo or secondary), and patient characteristics like performance&#xD;
             score, concomitant diagnoses, organ dysfunctions).&#xD;
&#xD;
          5. Patient is eligible for Low-Dose Cytarabine (LDAC) treatment.&#xD;
&#xD;
          6. Eastern co-operative oncology group (ECOG) performance score &lt;= 2 at screening.&#xD;
&#xD;
          7. Signed and dated written informed consent by start date of Screening visit in&#xD;
             accordance with Good Clinical Practice (GCP) and local legislation.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Prior or concomitant chemotherapy for AML (with the exception of hydroxyurea and/or&#xD;
             corticosteroid therapy for no more than 28 days (cumulative)). Please note that any&#xD;
             prior therapy for MDS is allowed.&#xD;
&#xD;
          2. Treatment with any investigational drug within 2 weeks before first administration of&#xD;
             present trial drug.&#xD;
&#xD;
          3. Acute promyelocytic leukaemia (French-American-British (FAB) classification subtype&#xD;
             M3).&#xD;
&#xD;
          4. Current clinical central nervous system (CNS) symptoms deemed by the investigator to&#xD;
             be related to leukaemic CNS involvement (no lumbar puncture required, clinical&#xD;
             assessment per investigator´s judgement is sufficient).&#xD;
&#xD;
          5. Hypersensitivity to one of the trial drugs or the excipients.&#xD;
&#xD;
          6. Severe illness or organ dysfunction involving the heart, kidney, liver or other organ&#xD;
             system (e.g. active infection, clinically relevant impairment of cardiac function,&#xD;
             severe heart failure/cardiac insufficiency, unstable angina pectoris or history of&#xD;
             recent myocardial infarction), which in the opinion of the investigator precludes&#xD;
             treatment with LDAC.&#xD;
&#xD;
          7. Corrected QT interval according to Fridericia (QTcF) prolongation &gt; 470 ms or QT&#xD;
             prolongation deemed clinically relevant by the investigator (e.g., congenital long QT&#xD;
             syndrome).The QTcF will be calculated as the mean of the 3 Electrocardiogram (ECGs)&#xD;
             taken at screening.&#xD;
&#xD;
          8. Total bilirubin &gt; 3 x upper limit of normal (ULN).&#xD;
&#xD;
          9. Creatinine clearance (CLcr) &lt; 30 ml/min (estimated creatinine clearance by the&#xD;
             Cockcroft-Gault (C-G) equation) .&#xD;
&#xD;
         10. Active hepatitis B or hepatitis C, or laboratory evidence for a chronic infection.&#xD;
&#xD;
         11. HIV infection.&#xD;
&#xD;
         12. Second malignancy currently requiring active therapy (except for&#xD;
             hormonal/anti-hormonal treatment e.g. in prostate or breast cancer).&#xD;
&#xD;
         13. Any significant concurrent psychiatric disorder or social situation that according to&#xD;
             the investigator´s judgement would compromise patient´s safety or compliance,&#xD;
             interfere with consent, study participation, or interpretation of study results.&#xD;
&#xD;
         14. Known or suspected active alcohol or drug abuse.&#xD;
&#xD;
         15. Patient unable to comply with the protocol, in the opinion of the investigator.&#xD;
&#xD;
         16. Male patients with partners of childbearing potential who are unwilling to use condoms&#xD;
             in combination with a second medically acceptable method of contraception during the&#xD;
             trial and for a minimum of 6 months after study treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boehringer Ingelheim</last_name>
    <role>Study Chair</role>
    <affiliation>Boehringer Ingelheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095-1678</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Hospital Association of Duluth, Inc.</name>
      <address>
        <city>Duluth</city>
        <state>Minnesota</state>
        <zip>55805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry-Joyce Cancer Clinic</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Texas 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>Fundacion COIR</name>
      <address>
        <city>Mendoza</city>
        <zip>M5500AYB</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Central de Salud Zenón Santillan</name>
      <address>
        <city>San Miguel de Tucumán</city>
        <zip>T4000HXU</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LKH-Univ. Hospital Graz</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LKH Leoben</name>
      <address>
        <city>Leoben</city>
        <zip>8700</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Hietzing</name>
      <address>
        <city>Wien</city>
        <zip>1130</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Sint-Jan Brugge</name>
      <address>
        <city>Brugge</city>
        <zip>8000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brussels - UNIV Saint-Luc</name>
      <address>
        <city>Bruxelles</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haine-St-Paul - HOSP Jolimont</name>
      <address>
        <city>Haine-Saint-Paul</city>
        <zip>7100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jessa Ziekenhuis - Campus Virga Jesse</name>
      <address>
        <city>Hasselt</city>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Liège</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Roeselare - HOSP AZ Delta</name>
      <address>
        <city>Roeselare</city>
        <zip>8800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yvoir - UNIV UCL de Mont-Godinne</name>
      <address>
        <city>Yvoir</city>
        <zip>5530</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Doutor Amaral Carvalho</name>
      <address>
        <city>Jau</city>
        <zip>17210-080</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Mãe de Deus</name>
      <address>
        <city>Porto Alegre</city>
        <zip>90470-340</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H.C.da Fac. de Medicina de Ribeirao Preto</name>
      <address>
        <city>Ribeirao Preto</city>
        <zip>14048-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Alberta Hospital (University of Alberta)</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2G3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vancouver General Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maisonneuve-Rosemont Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Migration Data</state>
        <zip>H1T 2M4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montreal General Hospital - McGill University Health Centre</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3G 1A4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Hradec Kralove</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>500 05</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Plzen, Plzen-Lochotin</name>
      <address>
        <city>Plzen - Lochotin</city>
        <zip>304 60</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ. Hospital Kralovske Vinohrady</name>
      <address>
        <city>Praha 10</city>
        <zip>100 34</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meilahden sairaala</name>
      <address>
        <city>Helsinki</city>
        <zip>00290</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TYKS, Sisätautien klinikka</name>
      <address>
        <city>Turku</city>
        <zip>20521</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Amiens-Picardie Sud</name>
      <address>
        <city>Amiens</city>
        <zip>80054</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Côte de Nacre</name>
      <address>
        <city>Caen</city>
        <zip>14000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Michallon</name>
      <address>
        <city>La Tronche</city>
        <zip>38700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP André Mignot</name>
      <address>
        <city>Le Chesnay</city>
        <zip>78157</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Dupuytren 1</name>
      <address>
        <city>Limoges Cedex 1</city>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>INS Paoli-Calmettes</name>
      <address>
        <city>Marseille</city>
        <zip>13273</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Nantes, Hémato, Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Saint-Antoine</name>
      <address>
        <city>Paris Cedex 12</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Haut-Lévêque</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Lyon Sud</name>
      <address>
        <city>Pierre Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Pontchaillou</name>
      <address>
        <city>Rennes Cedex 9</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>INS Universitaire du Cancer</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Augsburg</name>
      <address>
        <city>Augsburg</city>
        <zip>86156</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Med. Klinik m.S. Hämatologie und Onkologie</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Städtisches Klinikum Braunschweig gGmbH</name>
      <address>
        <city>Braunschweig</city>
        <zip>38114</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Erlangen</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Frankfurt</name>
      <address>
        <city>Frankfurt/Main</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin Göttingen, Georg-August-Universität</name>
      <address>
        <city>Göttingen</city>
        <zip>37075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Martin-Luther-Universität Halle-Wittenberg</name>
      <address>
        <city>Halle (Saale)</city>
        <zip>06120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Hamburg-Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Schleswig-Holstein, Campus Kiel</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin der Johannes Gutenberg-Universität Mainz</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Gießen und Marburg GmbH</name>
      <address>
        <city>Marburg</city>
        <zip>35043</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum rechts der Isar der Technischen Universität München</name>
      <address>
        <city>München</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Münster</name>
      <address>
        <city>Münster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Regensburg</name>
      <address>
        <city>Regensburg</city>
        <zip>93053</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Robert-Bosch-Krankenhaus GmbH</name>
      <address>
        <city>Stuttgart</city>
        <zip>70376</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Ulm</name>
      <address>
        <city>Ulm</city>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schwarzwald-Baar Klinikum</name>
      <address>
        <city>Villingen-Schwenningen</city>
        <zip>78052</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Athens &quot;G. Gennimatas&quot;</name>
      <address>
        <city>Athens</city>
        <zip>115 27</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Athens &quot;Laiko&quot;</name>
      <address>
        <city>Athens</city>
        <zip>11526</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ. Gen. Hosp. of Ioannina</name>
      <address>
        <city>Ioannina</city>
        <zip>45 500</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Patras Medical School</name>
      <address>
        <city>Patras</city>
        <zip>26504</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Thessaloniki &quot;G. Papanikolaou&quot;</name>
      <address>
        <city>Thessaloniki</city>
        <zip>57010</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Semmelweis University</name>
      <address>
        <city>Budapest</city>
        <zip>1083</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Petz Aldar Hospital, 2nd Dept. of Internal Med., Haematology</name>
      <address>
        <city>Gyor</city>
        <zip>9024</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ. of Szeged, 2nd Dept. of Internal Med., Haematology</name>
      <address>
        <city>Szeged</city>
        <zip>6725</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. John Medical College and hospital</name>
      <address>
        <city>Bangalore</city>
        <zip>560034</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tata Memorial Hospital</name>
      <address>
        <city>Mumbai</city>
        <zip>400012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. Spedali Civili di Brescia</name>
      <address>
        <city>Brescia</city>
        <zip>25123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Grande Ospedale Metropolitano Niguarda</name>
      <address>
        <city>Milano</city>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AO Città della Salute e della</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Nagoya Medical Center</name>
      <address>
        <city>Aichi, Nagoya</city>
        <zip>460-0001</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Japanese Red Cross Nagoya Daini Hospital</name>
      <address>
        <city>Aichi, Nagoya</city>
        <zip>466-8650</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akita University Hospital</name>
      <address>
        <city>Akita, Akita</city>
        <zip>010-8543</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Fukui Hospital</name>
      <address>
        <city>Fukui, Yoshida-gun</city>
        <zip>910-1193</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyushu University Hospital</name>
      <address>
        <city>Fukuoka, Fukuoka</city>
        <zip>812-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kobe University Hospital</name>
      <address>
        <city>Hyogo, Kobe</city>
        <zip>650-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokai University Hospital</name>
      <address>
        <city>Kanagawa, Isehara</city>
        <zip>259-1193</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yokohama City University Medical Center</name>
      <address>
        <city>Kanagawa, Yokohama</city>
        <zip>232-0024</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tohoku University Hospital</name>
      <address>
        <city>Miyagi, Sendai</city>
        <zip>980-8547</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagasaki University Hospital</name>
      <address>
        <city>Nagasaki, Nagasaki</city>
        <zip>852-8523</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kurashiki Central Hospital</name>
      <address>
        <city>Okayama, Kurashiki</city>
        <zip>710-8602</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okayama University Hospital</name>
      <address>
        <city>Okayama, Okayama</city>
        <zip>700-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka City University Hospital</name>
      <address>
        <city>Osaka, Osaka</city>
        <zip>545-8586</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital</name>
      <address>
        <city>Tokyo, Chuo-ku</city>
        <zip>104-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NTT Medical Center Tokyo</name>
      <address>
        <city>Tokyo, Sinagawa-ku</city>
        <zip>141-8625</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chonnam National University Hwasun Hospital</name>
      <address>
        <city>Hwasun</city>
        <zip>519-763</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, Seoul St.Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>138-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Dr Jose Eleuterio Gonzalez</name>
      <address>
        <city>Monterrey</city>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amsterdam UMC Locatie VUMC</name>
      <address>
        <city>Amsterdam</city>
        <zip>1081 HV</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haukeland Universitetssykehus</name>
      <address>
        <city>Bergen</city>
        <zip>N-5021</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sykehuset Østfold Kalnes</name>
      <address>
        <city>Grålum</city>
        <zip>N-1714</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reg. Specialist Hospital of M. Kopernik, Dept. Haematology</name>
      <address>
        <city>Lodz</city>
        <zip>93-510</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Hospital Torun, Department of Hematology</name>
      <address>
        <city>Torun</city>
        <zip>87-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHULN, EPE - Hospital de Santa Maria</name>
      <address>
        <city>Lisboa</city>
        <zip>1649-035</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António</name>
      <address>
        <city>Porto</city>
        <zip>4099-001</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IPO Porto Francisco Gentil, EPE</name>
      <address>
        <city>Porto</city>
        <zip>4200-072</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Universitário São João,EPE</name>
      <address>
        <city>Porto</city>
        <zip>4202-451</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Clinical Hospital 'The Badge of Honor Order'</name>
      <address>
        <city>Irkutsk</city>
        <zip>664079</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FSBI &quot;N.N Blokhin Med.Res.Cent.Onc.&quot;MoH of RF</name>
      <address>
        <city>Moscow</city>
        <zip>115478</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nizhniy Novgorod Reg. Clinical Hospital, Dept. Haematology</name>
      <address>
        <city>Nizhniy Novgorod</city>
        <zip>603126</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leningrad Reg. Clin. Hosp., Oncohematology Department No. 2</name>
      <address>
        <city>St. Petersburg</city>
        <zip>194291</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Netcare Pretoria East Hospital</name>
      <address>
        <city>Moreleta Park, Pretoria</city>
        <zip>0044</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Germans Trias i Pujol</name>
      <address>
        <city>Badalona</city>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Salamanca</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Politècnic La Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46009</zip>
        <country>Spain</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Chang-Hua Christian Hospital</name>
      <address>
        <city>ChangHua</city>
        <zip>500</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mackay Memorial Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>India</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Mexico</country>
    <country>Netherlands</country>
    <country>Norway</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Russian Federation</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
    <country>Malaysia</country>
    <country>Thailand</country>
  </removed_countries>
  <link>
    <url>http://www.mystudywindow.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <results_first_submitted>September 9, 2021</results_first_submitted>
  <results_first_submitted_qc>October 25, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">November 19, 2021</results_first_posted>
  <disposition_first_submitted>October 14, 2014</disposition_first_submitted>
  <disposition_first_submitted_qc>November 19, 2014</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">December 4, 2014</disposition_first_posted>
  <last_update_submitted>February 6, 2023</last_update_submitted>
  <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>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>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).&#xD;
For more details refer to: https://www.mystudywindow.com/msw/datatransparency</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients aged 65 years or more with previously untreated acute myeloid leukaemia, who are ineligible for intensive remission induction therapy were recruited in the phase III randomised, double-blind, placebo-controlled, parallel group study.</recruitment_details>
      <pre_assignment_details>All patients were screened for eligibility to participate in the trial. Patients attended a specialist sites which ensured that they (the patients) met all strictly implemented inclusion/exclusion criteria. Patients were not to be randomized to trial treatment if any one of the specific entry criteria was violated.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo + Low-dose Cytarabine</title>
          <description>Patients received placebo matching to Volasertib 350 milligram (mg) intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.</description>
        </group>
        <group group_id="P2">
          <title>Volasertib + Low-dose Cytarabine</title>
          <description>Patients received Volasertib 350 mg intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, wherein no dose increase was allowed after a dose reduction, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day 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="222"/>
                <participants group_id="P2" count="444"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="221"/>
                <participants group_id="P2" count="440"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="222"/>
                <participants group_id="P2" count="444"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Not treated</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Disease progression / relapse</title>
              <participants_list>
                <participants group_id="P1" count="123"/>
                <participants group_id="P2" count="156"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="165"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Reason not listed</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="63"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor terminated trial</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The randomised set (RS) included all patients who had been randomised at the database snapshot.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo + Low-dose Cytarabine</title>
          <description>Patients received placebo matching to Volasertib 350 milligram (mg) intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.</description>
        </group>
        <group group_id="B2">
          <title>Volasertib + Low-dose Cytarabine</title>
          <description>Patients received Volasertib 350 mg intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, wherein no dose increase was allowed after a dose reduction, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="222"/>
            <count group_id="B2" value="444"/>
            <count group_id="B3" value="666"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75.5" spread="4.9"/>
                    <measurement group_id="B2" value="75.2" spread="5.4"/>
                    <measurement group_id="B3" value="75.3" spread="5.2"/>
                  </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="87"/>
                    <measurement group_id="B2" value="203"/>
                    <measurement group_id="B3" value="290"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="135"/>
                    <measurement group_id="B2" value="241"/>
                    <measurement group_id="B3" value="376"/>
                  </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="10"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="194"/>
                    <measurement group_id="B2" value="399"/>
                    <measurement group_id="B3" value="593"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="47"/>
                  </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="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="113"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="158"/>
                    <measurement group_id="B2" value="328"/>
                    <measurement group_id="B3" value="486"/>
                  </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_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Objective Response (OR)</title>
        <description>OR is the number of patients who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi), where OR was based on the best response attained during the treatment period.</description>
        <time_frame>Response assessment was performed at the end of every 2nd cycle, (i.e. at the end of Cycle 2, 4, 6, 8, etc., and at end of treatment), i.e. up to 52 months.</time_frame>
        <population>The randomised set (RS) included all patients who had been randomised at the database snapshot.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + Low-dose Cytarabine</title>
            <description>Patients received placebo matching to Volasertib 350 milligram (mg) intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Volasertib + Low-dose Cytarabine</title>
            <description>Patients received Volasertib 350 mg intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, wherein no dose increase was allowed after a dose reduction, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response (OR)</title>
          <description>OR is the number of patients who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi), where OR was based on the best response attained during the treatment period.</description>
          <population>The randomised set (RS) included all patients who had been randomised at the database snapshot.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="222"/>
                <count group_id="O2" value="444"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This analysis was exploratory and descriptive.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The 2-sided test of the hypothesis was performed at a 0.05 level of significance. An odds ratio (OR) = 1 would indicate that the odds of achieving CR+CRi with Volasertib + Low-dose Cytarabine is equal to the odds of achieving CR+CRi with Placebo + Low-dose Cytarabine , whereas an OR ≠ 1 would indicate the opposite. H0, CR+CRi: OR = 1 vs. Ha, CR+CRi: OR ≠ 1.</non_inferiority_desc>
            <p_value>0.0024</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.8751</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.2432</ci_lower_limit>
            <ci_upper_limit>2.8281</ci_upper_limit>
            <estimate_desc>Common odds ratio is calculated by Mantel-Haenszel estimate adjusting for the two stratification factors (baseline Eastern Cooperative Oncology Group (ECOG) and type of AML). If odds ratio is above 1 then it favours Volasertib+Low-dose Cytarabine.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>OS is the key secondary endpoint and was measured from the date of randomization until death from any cause. Patients who were lost to follow-up were censored on the last date they were known to be alive.</description>
        <time_frame>From randomization until death due to any cause, up to 1557 days.</time_frame>
        <population>RS</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + Low-dose Cytarabine</title>
            <description>Patients received placebo matching to Volasertib 350 milligram (mg) intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Volasertib + Low-dose Cytarabine</title>
            <description>Patients received Volasertib 350 mg intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, wherein no dose increase was allowed after a dose reduction, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>OS is the key secondary endpoint and was measured from the date of randomization until death from any cause. Patients who were lost to follow-up were censored on the last date they were known to be alive.</description>
          <population>RS</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="222"/>
                <count group_id="O2" value="444"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" lower_limit="4.9" upper_limit="8.0"/>
                    <measurement group_id="O2" value="5.6" lower_limit="4.5" upper_limit="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This analysis was exploratory and descriptive.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The hazard ratio (HR) between Volasertib + Low-dose Cytarabine and Placebo + Low-dose Cytarabine was tested against 1. The null hypothesis, H0,OS, was that the hazards are equal between Volasertib + Low-dose Cytarabine and Placebo + Low-dose Cytarabine, whereas the alternative hypothesis, Ha,OS, was that the hazards are not equal between the 2 treatment arms. H0, OS: HR = 1 vs. Ha, OS: HR ≠ 1.</non_inferiority_desc>
            <p_value>0.7571</p_value>
            <p_value_desc>P-value is calculated from log-rank test stratified by baseline ECOG (0-1 vs. 2) and type of AML (denovo vs. secondary).</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.8</ci_lower_limit>
            <ci_upper_limit>1.2</ci_upper_limit>
            <estimate_desc>Hazard ratio is calculated from Cox proportional hazard model stratified by baseline ECOG and type of AML. If hazard ratio is below 1 then it favours volasertib.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Event-free Survival (EFS)</title>
        <description>EFS was measured from the date of randomisation to the date of progression or relapse, or death from any cause, whichever occurred first.</description>
        <time_frame>From randomization until disease progression or relapse or death from any cause, up to 1557 days.</time_frame>
        <population>RS</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + Low-dose Cytarabine</title>
            <description>Patients received placebo matching to Volasertib 350 milligram (mg) intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Volasertib + Low-dose Cytarabine</title>
            <description>Patients received Volasertib 350 mg intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, wherein no dose increase was allowed after a dose reduction, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Event-free Survival (EFS)</title>
          <description>EFS was measured from the date of randomisation to the date of progression or relapse, or death from any cause, whichever occurred first.</description>
          <population>RS</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="222"/>
                <count group_id="O2" value="444"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" lower_limit="2.1" upper_limit="4.9"/>
                    <measurement group_id="O2" value="3.3" lower_limit="2.6" upper_limit="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This analysis was exploratory and descriptive.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The hazard ratio (HR) between Volasertib + Low-dose Cytarabine and Placebo + Low-dose Cytarabine was tested against 1. The null hypothesis, H0,OS, was that the hazards are equal between Volasertib + Low-dose Cytarabine and Placebo + Low-dose Cytarabine, whereas the alternative hypothesis, Ha,OS, was that the hazards are not equal between the 2 treatment arms. H0, OS: HR = 1 vs. Ha, OS: HR ≠ 1.</non_inferiority_desc>
            <p_value>0.6718</p_value>
            <p_value_desc>P-value is calculated from log-rank test stratified by baseline ECOG (0-1 vs. 2) and type of AML (denovo vs. secondary).</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.8</ci_lower_limit>
            <ci_upper_limit>1.2</ci_upper_limit>
            <estimate_desc>Hazard ratio is calculated from Cox proportional hazard model stratified by baseline ECOG and type of AML. If hazard ratio is below 1 then it favours volasertib.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Relapse-free Survival (RFS)</title>
        <description>RFS was defined only for patients who achieved best overall response of CR or CRi; it was measured from the date of achievement of a remission until the date of relapse or death from any cause. Patients not known to have relapsed or died at last follow-up were censored on the date they were last examined.</description>
        <time_frame>From randomization until disease progression or relapse or death from any cause, up to 1557 days.</time_frame>
        <population>All patients in the RS who achieved best overall response of CR or CRi.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + Low-dose Cytarabine</title>
            <description>Patients received placebo matching to Volasertib 350 milligram (mg) intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Volasertib + Low-dose Cytarabine</title>
            <description>Patients received Volasertib 350 mg intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, wherein no dose increase was allowed after a dose reduction, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Relapse-free Survival (RFS)</title>
          <description>RFS was defined only for patients who achieved best overall response of CR or CRi; it was measured from the date of achievement of a remission until the date of relapse or death from any cause. Patients not known to have relapsed or died at last follow-up were censored on the date they were last examined.</description>
          <population>All patients in the RS who achieved best overall response of CR or CRi.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="123"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.7" lower_limit="11.3" upper_limit="NA">Confidence limits for the quartiles cannot be estimated due to insufficient number of participants with events.</measurement>
                    <measurement group_id="O2" value="13.1" lower_limit="6.2" upper_limit="NA">Confidence limits for the quartiles cannot be estimated due to insufficient number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.37</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.7</ci_lower_limit>
            <ci_upper_limit>2.7</ci_upper_limit>
            <estimate_desc>Hazard ratio is calculated from Cox proportional hazard model stratified by baseline ECOG and type of AML. If hazard ratio is below 1 then it favours volasertib.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first drug administration until 21 days after last drug administration, i.e., up to 91.4 months.</time_frame>
      <desc>The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of Volasertib, placebo, or Low-dose Cytarabine. One patient was randomised to the Volasertib + Low-dose Cytarabine arm but only took Low-dose Cytarabine and was therefore allocated to the Placebo + Low-dose Cytarabine arm in the treated set.</desc>
      <group_list>
        <group group_id="E1">
          <title>Subjects Assigned to Placebo + Low-dose Cytarabine</title>
          <description>Patients received placebo matching to Volasertib 350 milligram (mg) intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.</description>
        </group>
        <group group_id="E2">
          <title>Subjects Assigned to Volasertib + Low-dose Cytarabine</title>
          <description>Patients received Volasertib 350 mg intravenous infusion for 1 hour on day 1 and day 15 of each 28-day cycle, wherein no dose increase was allowed after a dose reduction, in combination with Cytarabine 20 mg subcutaneous injection given twice daily at 12 hours interval from day 1 to 10 of each 28-day cycle.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="138" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="163" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="380" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Bone marrow failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Disseminated intravascular coagulation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Febrile bone marrow aplasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="42" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="203" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Haemolytic anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Haemorrhagic diathesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Haemorrhagic disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Hypofibrinogenaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Lymphadenitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Splenic infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Blood loss anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Arrhythmia supraventricular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Bradyarrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Cardiac disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Cardiogenic shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Cardiopulmonary failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Left ventricular dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Right ventricular failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Tachyarrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Ventricular fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Atrioventricular block</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Aplasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blindness transient</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Retinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Anal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Anal ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Gastric haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Gastrointestinal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Gingival bleeding</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Haemorrhoidal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Ileus paralytic</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Inguinal hernia strangulated</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Intestinal perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Large intestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Melaena</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Mesenteric panniculitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Mouth haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Neutropenic colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Odynophagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Rectal ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Diverticulum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Catheter site phlebitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Device related thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Induration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Mucosal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Performance status decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct stone</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Hepatic failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Liver injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Hepatic cytolysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergy to vaccine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Anal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Aspergillus infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Bacillus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Bacterial infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Bacterial sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Bronchopulmonary aspergillosis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Campylobacter sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Catheter site infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Cellulitis of male external genital organ</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Clostridium colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Colonic abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Enteritis infectious</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Enterobacter infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Enterobacter sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Enterococcal bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Enterococcal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Enterocolitis infectious</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Epididymitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Escherichia bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Escherichia infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Escherichia sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Escherichia urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Fungal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Fungal skin infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Genital herpes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Klebsiella infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Klebsiella sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Liver abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Lymphadenitis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Myocarditis septic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Neutropenic infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Neutropenic sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Oropharyngeal candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Osteomyelitis fungal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Parotitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Perichondritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Pharyngotonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="113" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Pneumonia fungal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Pneumonia klebsiella</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Pneumonia staphylococcal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Prostatitis Escherichia coli</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Pseudomembranous colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Pseudomonal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Pseudomonas infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Pulmonary sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Pulmonary tuberculosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Rash pustular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection fungal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="44" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Sinusitis aspergillus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Sinusitis fungal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Soft tissue infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Staphylococcal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Stenotrophomonas sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Streptococcal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Testicular abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Tonsillitis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Tuberculosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Vulvitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Clostridium bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Haematoma infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Large intestine infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Pneumonia influenzal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Pneumonia pseudomonal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Vascular device infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Allergic transfusion reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Extradural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Pelvic fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Subdural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Tracheal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Transfusion reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Transfusion-related acute lung injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Transfusion-related circulatory overload</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Wound haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Blood pressure orthostatic decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Electrocardiogram QT prolonged</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Haematocrit decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Troponin increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>White blood cell count increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Acidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Cachexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Hypercreatininaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Hypernatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Tumour lysis syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Gouty arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Haemarthrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Osteoporosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Synovitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Osteitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acute myeloid leukaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Chronic lymphocytic leukaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Malignant neoplasm of thorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Malignant neoplasm progression</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Metastases to peritoneum</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Neoplasm skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Rectal cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Tumour associated fever</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Myeloproliferative neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Brain stem haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Cerebellar haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Cerebral ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Embolic cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Haemorrhagic stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Hypotonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Sneddon's syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Stupor</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Disorientation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Mental disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Bladder obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Acute respiratory distress syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Dyspnoea at rest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Haemothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Lung disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Lung infiltration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Orthopnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Pulmonary haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Pulmonary hypertension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Respiratory tract haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Aspiration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acute febrile neutrophilic dermatosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Drug eruption</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Erythema nodosum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Skin haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Toxic skin eruption</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Angioplasty</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Hypertensive emergency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Hypovolaemic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Peripheral artery thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Phlebitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Venous thrombosis limb</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Aortitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 24.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="203" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="404" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="53" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="137" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="101" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="124" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="59" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="163" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="47" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="55" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="122" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="49" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="116" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="79" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="123" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="75" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="71" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="42" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="64" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="62" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="63" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="36" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="42" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="75" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="58" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="85" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="38" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Electrocardiogram QT prolonged</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="39" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="82" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="120" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="50" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="43" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="48" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="38" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="95" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="76" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="71" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Petechiae</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="73" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="72" subjects_at_risk="439"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="55" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="439"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="439"/>
              </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>Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The final analysis presented in this report was conducted after 574 Overall Survival events had occurred. The final analysis was exploratory and descriptive.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Boehringer Ingelheim, Call Center</name_or_title>
      <organization>Boehringer Ingelheim</organization>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.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/NCT01721876
org study id: 1230.14
secondary id: 2012-002487-27
nct id: NCT01721876
lead sponsor: 
To investigate the efficacy, safety, and pharmacokinetics of intravenous volasertib +
      subcutaneous low dose cytarabine in patients >= 65 years of age with previously untreated
      acute myeloid leukaemia, ineligible for intensive remission induction therapy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Objective Response (OR)
time frame: Response assessment was performed at the end of every 2nd cycle, (i.e. at the end of Cycle 2, 4, 6, 8, etc., and at end of treatment), i.e. up to 52 months.
description: OR is the number of patients who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi), where OR was based on the best response attained during the treatment period.
measure: Overall Survival (OS)
time frame: From randomization until death due to any cause, up to 1557 days.
description: OS is the key secondary endpoint and was measured from the date of randomization until death from any cause. Patients who were lost to follow-up were censored on the last date they were known to be alive.
measure: Event-free Survival (EFS)
time frame: From randomization until disease progression or relapse or death from any cause, up to 1557 days.
description: EFS was measured from the date of randomisation to the date of progression or relapse, or death from any cause, whichever occurred first.
measure: Relapse-free Survival (RFS)
time frame: From randomization until disease progression or relapse or death from any cause, up to 1557 days.
description: RFS was defined only for patients who achieved best overall response of CR or CRi; it was measured from the date of achievement of a remission until the date of relapse or death from any cause. Patients not known to have relapsed or died at last follow-up were censored on the date they were last examined.
arm group label: Volasertib and Cytarabine
arm group type: Experimental
arm group label: Placebo and Cytarabine
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Placebo
description: Placebo matching Volasertib
arm group label: Placebo and Cytarabine
intervention type: Drug
intervention name: Volasertib
description: Volasertib
arm group label: Volasertib and Cytarabine
intervention type: Drug
intervention name: Cytarabine
description: Cytarabine
arm group label: Placebo and Cytarabine
arm group label: Volasertib and Cytarabine
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
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country: Argentina
country: Austria
country: Belgium
country: Brazil
country: Canada
country: Czechia
country: Finland
country: France
country: Germany
country: Greece
country: Hungary
country: India
country: Italy
country: Japan
country: Korea, Republic of
country: Mexico
country: Netherlands
country: Norway
country: Poland
country: Portugal
country: Russian Federation
country: South Africa
country: Spain
country: Taiwan
country: United States
country: Czech Republic
country: Malaysia
country: Thailand
url: http://www.mystudywindow.com/
description: Related Info
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Cytarabine
sharing ipd: No
ipd description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datatransparency
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The final analysis presented in this report was conducted after 574 Overall Survival events had occurred. The final analysis was exploratory and descriptive.
point of contact: 