<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/NCT02228382</url>
  </required_header>
  <id_info>
    <org_study_id>B1871039</org_study_id>
    <secondary_id>2013-003250-25</secondary_id>
    <secondary_id>BYOND</secondary_id>
    <nct_id>NCT02228382</nct_id>
  </id_info>
  <brief_title>Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors</brief_title>
  <official_title>A PHASE 4 SAFETY AND EFFICACY STUDY OF BOSUTINIB (BOSULIF (REGISTERED)) IN PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA PREVIOUSLY TREATED WITH ONE OR MORE TYROSINE KINASE INHIBITORS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Developmental Therapeutics Consortium</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to fulfill the post-authorization commitment made by Pfizer to&#xD;
      the European Medicines Agency in providing additional safety and efficacy data in&#xD;
      approximately 150 Philadelphia Chromosome Positive Chronic Myeloid Leukemia patients with&#xD;
      high unmet medical need, including 75 Chronic Phase, Accelerated Phase or Blast Phase&#xD;
      patients in the fourth or later line treatment setting (i.e., after treatment with at least 3&#xD;
      other Tyrosine Kinase Inhibitors).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date type="Actual">November 7, 2014</start_date>
  <completion_date type="Actual">October 13, 2020</completion_date>
  <primary_completion_date type="Actual">October 13, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Cumulative Confirmed Major Cytogenetic Response (MCyR) in 2nd and 3rd Line Chronic Phase (CP) Participants</measure>
    <time_frame>Up to 1 year (52 weeks)</time_frame>
    <description>Confirmed MCyR: confirmed (complete cytogenetic response[CCyR] or partial cytogenetic response[PCyR]) by 1 year for participants entering the study without CCyR or maintenance of confirmed CCyR for at least 1 year after treatment start with bosutinib for participants entering the study with CCyR or at least major molecular response(MMR) by 1 year and a deeper molecular response compared to baseline. Participants with baseline PCyR that did not achieve CCyR were counted as nonresponders. Initial cytogenetic (in absence of MMR) responses must have been confirmed by 2 consecutive assessments &gt;=28 days apart. CCyR: 0% Ph+ cells from &gt;=20 metaphases from conventional cytogenetics or &lt;1% Ph+ cells from &gt;= 200 cells from fluorescent in situ hybridization(FISH). PCyR: 1 to 35% Ph+ cells. MMR: &lt;=0.1% BCR-ABL1 on the international scale (IS) with at least 10,000 ABL1 transcripts assessed by central laboratory.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Cumulative Confirmed Major Cytogenetic Response (MCyR) in 4th or Later Line Chronic Phase (CP) Participants</measure>
    <time_frame>Up to 1 year (52 weeks)</time_frame>
    <description>Confirmed MCyR: confirmed CCyR or PCyR by 1 year for participants entering the study without CCyR or maintenance of confirmed CCyR for at least 1 year after treatment start with bosutinib for participants entering the study with CCyR or at least MMR by 1 year and a deeper molecular response compared to baseline. Participants with baseline PCyR that did not achieve CCyR were counted as nonresponders. Initial cytogenetic (in absence of MMR) responses must have been confirmed by 2 consecutive assessments &gt;=28 days apart. CCyR: 0% Ph+ cells from &gt;=20 metaphases from conventional cytogenetics or &lt;1% Ph+ cells from &gt;= 200 cells from fluorescent in situ hybridization(FISH). PCyR: 1 to 35% Ph+ cells. MMR: &lt;=0.1% BCR-ABL1 on the IS with at least 10,000 ABL1 transcripts assessed by central laboratory.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Cumulative Confirmed Overall Hematological Response (OHR) in Accelerated Phase (AP) Chronic Myelogenous Leukemia (CML) Participants</measure>
    <time_frame>Up to 1 year (52 weeks)</time_frame>
    <description>Confirmed OHR was defined as complete hematological response (CHR) or return to chronic phase (RCP) by 1 year in AP and BP participants. CHR was defined as white blood cells (WBC) &lt;10*10^9/L, peripheral blood basophils &lt;5%, no peripheral blood myelocytes, promyelocytes, myeloblasts in the differential, platelet count &lt;450*10^9/L, spleen not palpable. Hematologic responses must be of &gt;=4 weeks duration confirmed by 2 assessments &gt;=4 weeks apart.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Cumulative Major Cytogenetic Response (MCyR)</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>CyR was based on prevalence of Ph+ cells. CCyR was achieved when there was 0 % Ph+ cells from &gt;=20 metaphases from conventional bone marrow cytogenetics or &lt;1% Ph+ cells from &gt;=200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present. MCyR was categorized as either CCyR or PCyR. Participants with MMR or better at baseline were counted as CCyR if baseline response was maintained or improved while on treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Cumulative Confirmed Overall Hematological Response (OHR) in Participants With Accelerated Phase (AP) Chronic Myelogenous Leukemia (CML)</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>Confirmed OHR was defined as CHR or RCP in AP and BP participants. CHR was defined as WBC &lt;10*10^9/L, peripheral blood basophils &lt;5%, no peripheral blood myelocytes, promyelocytes, myeloblasts in the differential, platelet count &lt;450*10^9/L, spleen not palpable. Hematologic responses must be of &gt;=4 weeks duration confirmed by 2 assessments &gt;=4 weeks apart.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Cumulative Best Response</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>Hierarchy best response: %participants with best response among molecular/cytogenetic/hematologic response. Molecular response:MR4.5/MR4/MMR defined as &lt;=0.0032/0.01/0.1% BCR-ABL1 ratio on IS corresponding to &gt;=4.5/4/3-log reduction from standardised baseline with at least 32,000/10,000/10,000 ABL1 assessed by central laboratory. CyR:based on prevalence of Ph+cells. CCyR: 0% Ph+cells from &gt;=20 metaphases from conventional cytogenetics or &lt;1%Ph+cells from &gt;=200 cells from FISH. PCyR:1 to 35% Ph+cells. CHR:WBC &lt;10*10^9/L, peripheral blood basophils&lt;5%, no peripheral blood myelocytes, promyelocytes, myeloblasts in differential, platelet count&lt;450*10^9/L, spleen not palpable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Major Cytogenetic Response (MCyR) at Months 3, 6, 12, 18 and 24</measure>
    <time_frame>Months 3, 6, 12, 18, and 24</time_frame>
    <description>CyR was based on prevalence of Ph+ cells. CCyR was achieved when there was 0 % Ph+ cells from &gt;=20 metaphases from conventional bone marrow cytogenetics or &lt;1% Ph+ cells from &gt;=200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present. MCyR was categorized as either CCyR or PCyR. Participants with MMR or better at baseline were counted as CCyR if baseline response was maintained or improved while on treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Accelerated Phase Participants With Confirmed Overall Hematological Response (OHR) at Month 3, 6, 9, 12, 18, and 24</measure>
    <time_frame>Months 3, 6, 9, 12, 18, and 24</time_frame>
    <description>Confirmed OHR was defined as CHR or RCP in AP and BP participants. CHR was defined as WBC &lt;10*10^9/L, peripheral blood basophils &lt;5%, no peripheral blood myelocytes, promyelocytes, myeloblasts in the differential, platelet count &lt;450*10^9/L, spleen not palpable. Hematologic responses must be of &gt;=4 weeks duration confirmed by 2 assessments &gt;=4 weeks apart.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Cumulative Confirmed Complete Hematological Response (CHR)</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>CHR was defined as WBC &lt;10*10^9/L, peripheral blood basophils &lt;5%, no peripheral blood myelocytes, promyelocytes, myeloblasts in the differential, platelet count &lt;450*10^9/L, spleen not palpable. Hematologic responses must be of &gt;=4 weeks duration confirmed by 2 assessments &gt;=4 weeks apart.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Cumulative Major Molecular Response (MMR)</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>Molecular response: MR4.5/MR4/MMR defined as &lt;=0.0032/0.01/0.1% BCR-ABL1 ratio respectively, on IS corresponding to &gt;=4.5/4/3-log reduction from standardized baseline with at least 32,000/10,000/10,000 ABL1 assessed by central laboratory. To be considered a responder, the participant must have had maintenance of baseline response while on-treatment or an improvement from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kaplan-Meier Estimate of Probability of Retaining Complete Cytogenetic Response (CCyR) at Month 36</measure>
    <time_frame>At Month 36</time_frame>
    <description>Kaplan-Meier analysis. Duration of CCyR: from first date of CCyR to date of confirmed loss of CCyR/disease progression/on-treatment death or censoring, analyzed for responders only. CyR: prevalence of Ph+ cells. CCyR: 0% Ph+ cells from &gt;=20 metaphases from conventional cytogenetics or &lt;1% Ph+ cells from &gt;=200 cells analyzed by FISH or MMR (&lt;=0.1% BCR-ABL1 on the IS with at least 10,000 ABL1 transcripts assessed by central laboratory). Confirmed loss: 2 consecutive non-response assessments &gt;=28 days apart. Progression: for CP: participants evolving from CP to AP, loss of CHR; loss of MCyR; in participants without CHR WBC &gt;20*10^9/L on 2 occasions &gt;=2 weeks apart after the first 4 weeks of treatment; for AP: confirmed BP, loss of previous hematologic response over a 2-week period, loss of CHR, no decrease from baseline levels (if considered clinically relevant) in percentage blasts in peripheral blood or bone marrow on all assessments over a 4-week period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kaplan-Meier Estimate of Probability of Retaining Major Molecular Response (MMR) at Month 36</measure>
    <time_frame>At Month 36</time_frame>
    <description>Kaplan-Meier analysis. Duration of MMR: from first date of MMR to confirmed loss of MMR/disease progression/on-treatment death or censoring, analyzed for responders only. MMR:&lt;=0.1% BCR-ABL1 on the IS with at least 10,000 ABL1 transcripts assessed by central laboratory . Confirmed loss: 2 consecutive non-response assessments &gt;=28 days apart with a &lt;3-log (&gt;0.1%) reduction in transcripts one of which corresponds to a &lt;=2-log reduction (&gt;=1%). Progression: for CP: participants evolving from CP to AP, loss of CHR; loss of MCyR; in participants without CHR WBC &gt;20*10^9/L on 2 occasions &gt;=2weeks apart after the first 4 weeks of treatment; for AP: confirmed BP, loss of previous hematologic response over a 2-week period, loss of CHR, no decrease from baseline levels (if considered clinically relevant) in percentage blasts in peripheral blood or bone marrow on all assessments over a 4-week period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs</measure>
    <time_frame>First dose of study drug up to 28 days after last dose (up to maximum of 4 years)</time_frame>
    <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAE: any event increasing in severity from baseline or any new event started during bosutinib therapy or within 28 days of the last dose of study drug. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Grade 3 or 4 Treatment Emergent Adverse Events (TEAEs) Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0</measure>
    <time_frame>First dose of study drug up to 28 days after last dose (up to maximum of 4 years)</time_frame>
    <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAE was any event increasing in severity from baseline or any new event that started during bosutinib therapy or within 28 days of the last dose of study drug. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Number of participants with Grade 3 or 4 TEAEs are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment Related Treatment Emergent Adverse Events (TEAEs)</measure>
    <time_frame>First dose of study drug up to 28 days after last dose (up to maximum of 4 years)</time_frame>
    <description>An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAE was any event increasing in severity from baseline or any new event that started during bosutinib therapy or within 28 days of the last dose of study drug. Relatedness to drug was assessed by investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Laboratory Abnormalities Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03</measure>
    <time_frame>First dose of study drug up to 28 days after last dose (up to maximum of 4 years)</time_frame>
    <description>Number of participants with any hematological, chemistry and coagulation abnormality of any grade were reported. Hematological: absolute neutrophil count (low), hemoglobin (low), lymphocytes (low), platelets (low) and leukocytes (low). Chemistry: alkaline phosphatase (high), alanine aminotransferase (high), amylase (high), aspartate aminotransferase (high), bilirubin (high), creatinine (high), lipase (high). Coagulation: activated partial prothrombin time (low), prothrombin time (low and high), partial prothrombin time (high).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">163</enrollment>
  <condition>Previously Treated PH + CML</condition>
  <arm_group>
    <arm_group_label>Bosutinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bosutinib</intervention_name>
    <description>100 mg and 500 mg tablets, once daily dosage up to 4 years duration</description>
    <arm_group_label>Bosutinib</arm_group_label>
    <other_name>BOSULIF</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed Philadelphia Chromosome positive Chronic Myeloid Leukemia or Confirmed&#xD;
             BCR-ABL1 (Abelson-break point cluster) Positive if Philadelphia Chromosome negative&#xD;
             Chronic Myeloid Leukemia (from initial diagnosis).&#xD;
&#xD;
          -  Prior treatment with 1 or more tyrosine kinase inhibitor drugs (imatinib, dasatinib&#xD;
             and/or nilotinib) for Philadelphia Chromosome positive Chronic Myeloid Leukemia (CML).&#xD;
&#xD;
          -  Any Chronic Myeloid Leukemia disease phase, as long as the patient is unable to&#xD;
             receive treatment with imatinib, dasatinib and/or nilotinib for any reason.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in any other clinical studies involving investigational drug(s) within&#xD;
             14 days or within 3 half-lives of drug levels in blood (whichever is longer) prior to&#xD;
             the first dose of bosutinib.&#xD;
&#xD;
          -  Prior treatment with bosutinib.&#xD;
&#xD;
          -  Prior treatment with ponatinib.&#xD;
&#xD;
          -  Known T315I or V299L mutation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Keck Hospital of USC</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LAC+USC Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USC/Norris Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sylvester Deerfield Beach</name>
      <address>
        <city>Deerfield Beach</city>
        <state>Florida</state>
        <zip>33442</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami Hospital &amp; Clinics</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana Blood and Marrow Transplantation-Clinic</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Siteman Cancer Center - West County</name>
      <address>
        <city>Creve Coeur</city>
        <state>Missouri</state>
        <zip>63141-6337</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barnes-Jewish Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Siteman Cancer Center - South County</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63129</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College - New York-Presbyterian Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Cancer Care Alliance</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universitaet Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordensklinikum Linz Gmbh Barmherzige Schwestern</name>
      <address>
        <city>Linz</city>
        <zip>4010</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Bergonie</name>
      <address>
        <city>Bordeaux Cedex 09</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Versailles (CHV)-Hopital Andre Mignot Service d'Hematologie Clinique- Oncology</name>
      <address>
        <city>Le Chesnay Cedex</city>
        <zip>78157</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Regional De Lutte Contre Le Cancer</name>
      <address>
        <city>Marseille</city>
        <zip>13009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Archet I</name>
      <address>
        <city>Nice Cedex 3</city>
        <zip>06202</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Universitaire du Cancer Toulouse - Oncopole</name>
      <address>
        <city>Toulouse Cedex 9</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Brabois</name>
      <address>
        <city>Vandoeuvre-les-Nancy cedex</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RWTH Uniklinik Aachen Klinik fur Onkologie, Hamatologie und Stammzelltransplantation</name>
      <address>
        <city>Aachen</city>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Hamburg-Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik fur Innere Medizin II</name>
      <address>
        <city>Jena</city>
        <zip>07747</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Koeln (AoeR)</name>
      <address>
        <city>Koeln</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>III. Medizinische Klinik Universitaetsmedizin Mannheim</name>
      <address>
        <city>Mannheim</city>
        <zip>D-68167</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU Policlinico Consorziale di Bari - UO Ematologia con Trapianto</name>
      <address>
        <city>Bari</city>
        <state>BA</state>
        <zip>70124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Policlinico S. Orsola-Malpighi</name>
      <address>
        <city>Bologna</city>
        <state>BO</state>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Socio Sanitaria Territoriale - ASST Monza</name>
      <address>
        <city>Monza</city>
        <state>MB</state>
        <zip>20900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale S. Eugenio - UOC Ematologia</name>
      <address>
        <city>Rome</city>
        <state>RM</state>
        <zip>00144</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU San Luigi Gonzaga SCDU Medicina Interna II ad indirizzo Ematologico</name>
      <address>
        <city>Orbassano</city>
        <state>TO</state>
        <zip>10043</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU Policlinico Vittorio Emanuele-P.O.G. Rodolico</name>
      <address>
        <city>Catania</city>
        <zip>95123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SOD Ematologia</name>
      <address>
        <city>Firenze</city>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. Ospedale Niguarda Ca Granda - SC Ematologia</name>
      <address>
        <city>Milano</city>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haukeland Universitetssjukehus</name>
      <address>
        <city>Bergen</city>
        <zip>5021</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Olav Hospital</name>
      <address>
        <city>Trondheim</city>
        <zip>7030</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Quiron Madrid</name>
      <address>
        <city>Pozuelo de Alarcon</city>
        <state>Madrid</state>
        <zip>28223</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d' Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic De Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de La Princesa</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramon y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Salamanca</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari i Politecnic La Fe de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de dia Quiron Zaragoza</name>
      <address>
        <city>Zaragoza</city>
        <zip>50012</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematologiskt centrum</name>
      <address>
        <city>Stockholm</city>
        <zip>171 76</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akademiska Sjukhuset</name>
      <address>
        <city>Uppsala</city>
        <zip>751 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Norway</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Belgium</country>
    <country>Finland</country>
    <country>Netherlands</country>
  </removed_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1871039&amp;StudyName=Safety%20And%20Efficacy%20Study%20Of%20Bosutinib%20In%20Patients%20With%20Philadelphia%20Chromosome%20Positive%20Chronic%20Myeloid%20Leukemia%20Previously%20Treated%20With%20</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <results_first_submitted>October 12, 2021</results_first_submitted>
  <results_first_submitted_qc>December 2, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">December 30, 2021</results_first_posted>
  <last_update_submitted>December 2, 2021</last_update_submitted>
  <last_update_submitted_qc>December 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bosutinib</keyword>
  <keyword>Chronic Myeloid Leukemia</keyword>
  <keyword>CML</keyword>
  <keyword>Leukemia</keyword>
  <keyword>Myelogenous</keyword>
  <keyword>Chronic</keyword>
  <keyword>BC-ABL Positive</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive</mesh_term>
    <mesh_term>Philadelphia Chromosome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
    <ipd_url>https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 7, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT02228382/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 12, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT02228382/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants with chronic phase (CP), accelerated phase (AP), or blast phase (BP) philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML), or breakpoint cluster region-abelson kinase (BCR-ABL1) positive and Philadelphia chromosome negative (Ph-), who failed prior treatment with commercially available tyrosine kinase inhibitors (TKIs) due to drug resistance or intolerance, or were otherwise contraindicated for treatment with commercially available TKIs were enrolled.</recruitment_details>
      <pre_assignment_details>A total of 177 participants signed the ICF, 14 participants were screen failure and 163 were enrolled into the study and assigned to study treatment. Reporting arms were based on line of therapy (CP2L, CP3L, CP4L) and disease phase (CP and AP). Data collection and planned analysis on BP participants was not performed because no participants with BP were enrolled in the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Bosutinib: Chronic Phase 2nd Line Chronic Myelogenous Leukemia</title>
          <description>Participants with philadelphia chromosome positive chronic phase 2nd line chronic myelogenous leukemia resistant or intolerant to imatinib, dasatinib, or nilotinib received bosutinib 500 milligram (mg), orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, death or discontinuation of study (up to maximum of 4 years). Participants who discontinued bosutinib prior to completing at least 4 years of therapy were followed for survival until they completed at least 4 years of follow-up from the time of first dose.</description>
        </group>
        <group group_id="P2">
          <title>Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia</title>
          <description>Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia resistant or intolerant to imatinib and/or dasatinib and/or nilotinib received bosutinib 500 mg, orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, death or discontinuation of study (up to maximum of 4 years). Participants who discontinued bosutinib prior to completing at least 4 years of therapy were followed for survival until they completed at least 4 years of follow-up from the time of first dose.</description>
        </group>
        <group group_id="P3">
          <title>Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia</title>
          <description>Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia resistant or intolerant to imatinib and dasatinib and nilotinib received bosutinib 500 mg, orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, death or discontinuation of study (up to maximum of 4 years). Participants who discontinued bosutinib prior to completing at least 4 years of therapy were followed for survival until they completed at least 4 years of follow-up from the time of first dose.</description>
        </group>
        <group group_id="P4">
          <title>Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia</title>
          <description>Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia resistant or intolerant to at least one tyrosine kinase inhibitor among imatinib, dasatinib, or nilotinib received bosutinib 500 mg, orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, death or discontinuation of study (up to maximum of 4 years). Participants who discontinued bosutinib prior to completing at least 4 years of therapy were followed for survival until they completed at least 4 years of follow-up from the time of first dose.</description>
        </group>
        <group group_id="P5">
          <title>Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia</title>
          <description>Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia received bosutinib 500 mg, orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, death or discontinuation of study (up to maximum of 4 years). Participants who discontinued bosutinib prior to completing at least 4 years of therapy were followed for survival until they completed at least 4 years of follow-up from the time of first dose.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="61"/>
                <participants group_id="P3" count="49"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="43"/>
                <participants group_id="P3" count="28"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="21"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant refused further follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study terminated by sponsor</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety analysis set included all participants who received at least 1 dose of bosutinib</population>
      <group_list>
        <group group_id="B1">
          <title>Bosutinib: Chronic Phase 2nd Line Chronic Myelogenous Leukemia</title>
          <description>Participants with philadelphia chromosome positive chronic phase 2nd line chronic myelogenous leukemia.</description>
        </group>
        <group group_id="B2">
          <title>Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia</title>
          <description>Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.</description>
        </group>
        <group group_id="B3">
          <title>Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia</title>
          <description>Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.</description>
        </group>
        <group group_id="B4">
          <title>Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia</title>
          <description>Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.</description>
        </group>
        <group group_id="B5">
          <title>Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia</title>
          <description>Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia.</description>
        </group>
        <group group_id="B6">
          <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="46"/>
            <count group_id="B2" value="61"/>
            <count group_id="B3" value="49"/>
            <count group_id="B4" value="4"/>
            <count group_id="B5" value="3"/>
            <count group_id="B6" value="163"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.8" spread="15.4"/>
                    <measurement group_id="B2" value="61.8" spread="15.0"/>
                    <measurement group_id="B3" value="59.4" spread="15.3"/>
                    <measurement group_id="B4" value="40.8" spread="11.0"/>
                    <measurement group_id="B5" value="64.3" spread="7.1"/>
                    <measurement group_id="B6" value="58.9" spread="15.4"/>
                  </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="23"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="75"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="44"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="143"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Cumulative Confirmed Major Cytogenetic Response (MCyR) in 2nd and 3rd Line Chronic Phase (CP) Participants</title>
        <description>Confirmed MCyR: confirmed (complete cytogenetic response[CCyR] or partial cytogenetic response[PCyR]) by 1 year for participants entering the study without CCyR or maintenance of confirmed CCyR for at least 1 year after treatment start with bosutinib for participants entering the study with CCyR or at least major molecular response(MMR) by 1 year and a deeper molecular response compared to baseline. Participants with baseline PCyR that did not achieve CCyR were counted as nonresponders. Initial cytogenetic (in absence of MMR) responses must have been confirmed by 2 consecutive assessments &gt;=28 days apart. CCyR: 0% Ph+ cells from &gt;=20 metaphases from conventional cytogenetics or &lt;1% Ph+ cells from &gt;= 200 cells from fluorescent in situ hybridization(FISH). PCyR: 1 to 35% Ph+ cells. MMR: &lt;=0.1% BCR-ABL1 on the international scale (IS) with at least 10,000 ABL1 transcripts assessed by central laboratory.</description>
        <time_frame>Up to 1 year (52 weeks)</time_frame>
        <population>Evaluable set for cytogenetic response: treated participants with valid baseline efficacy assessment (&gt;=20 metaphases from baseline bone marrow or CCyR with &gt;=200 cells from FISH or baseline MMR). Data for this outcome measure was not planned to be collected and analyzed for AP CML and Ph- participants and planned to be analyzed for 2nd line and 3rd line population.</population>
        <group_list>
          <group group_id="O1">
            <title>Bosutinib, Chronic Phase 2nd and 3rd Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic phase 2nd and 3rd line chronic myelogenous leukemia.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Cumulative Confirmed Major Cytogenetic Response (MCyR) in 2nd and 3rd Line Chronic Phase (CP) Participants</title>
          <description>Confirmed MCyR: confirmed (complete cytogenetic response[CCyR] or partial cytogenetic response[PCyR]) by 1 year for participants entering the study without CCyR or maintenance of confirmed CCyR for at least 1 year after treatment start with bosutinib for participants entering the study with CCyR or at least major molecular response(MMR) by 1 year and a deeper molecular response compared to baseline. Participants with baseline PCyR that did not achieve CCyR were counted as nonresponders. Initial cytogenetic (in absence of MMR) responses must have been confirmed by 2 consecutive assessments &gt;=28 days apart. CCyR: 0% Ph+ cells from &gt;=20 metaphases from conventional cytogenetics or &lt;1% Ph+ cells from &gt;= 200 cells from fluorescent in situ hybridization(FISH). PCyR: 1 to 35% Ph+ cells. MMR: &lt;=0.1% BCR-ABL1 on the international scale (IS) with at least 10,000 ABL1 transcripts assessed by central laboratory.</description>
          <population>Evaluable set for cytogenetic response: treated participants with valid baseline efficacy assessment (&gt;=20 metaphases from baseline bone marrow or CCyR with &gt;=200 cells from FISH or baseline MMR). Data for this outcome measure was not planned to be collected and analyzed for AP CML and Ph- participants and planned to be analyzed for 2nd line and 3rd line population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.5" lower_limit="66.9" upper_limit="84.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Cumulative Confirmed Major Cytogenetic Response (MCyR) in 4th or Later Line Chronic Phase (CP) Participants</title>
        <description>Confirmed MCyR: confirmed CCyR or PCyR by 1 year for participants entering the study without CCyR or maintenance of confirmed CCyR for at least 1 year after treatment start with bosutinib for participants entering the study with CCyR or at least MMR by 1 year and a deeper molecular response compared to baseline. Participants with baseline PCyR that did not achieve CCyR were counted as nonresponders. Initial cytogenetic (in absence of MMR) responses must have been confirmed by 2 consecutive assessments &gt;=28 days apart. CCyR: 0% Ph+ cells from &gt;=20 metaphases from conventional cytogenetics or &lt;1% Ph+ cells from &gt;= 200 cells from fluorescent in situ hybridization(FISH). PCyR: 1 to 35% Ph+ cells. MMR: &lt;=0.1% BCR-ABL1 on the IS with at least 10,000 ABL1 transcripts assessed by central laboratory.</description>
        <time_frame>Up to 1 year (52 weeks)</time_frame>
        <population>Evaluable set cytogenetic response: treated participants with valid baseline efficacy assessment (&gt;= 20 metaphases from baseline bone marrow or CCyR with &gt;=200 cells from FISH or baseline MMR). Data for this outcome measure was not planned to be collected and analyzed for AP CML and Ph-participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Cumulative Confirmed Major Cytogenetic Response (MCyR) in 4th or Later Line Chronic Phase (CP) Participants</title>
          <description>Confirmed MCyR: confirmed CCyR or PCyR by 1 year for participants entering the study without CCyR or maintenance of confirmed CCyR for at least 1 year after treatment start with bosutinib for participants entering the study with CCyR or at least MMR by 1 year and a deeper molecular response compared to baseline. Participants with baseline PCyR that did not achieve CCyR were counted as nonresponders. Initial cytogenetic (in absence of MMR) responses must have been confirmed by 2 consecutive assessments &gt;=28 days apart. CCyR: 0% Ph+ cells from &gt;=20 metaphases from conventional cytogenetics or &lt;1% Ph+ cells from &gt;= 200 cells from fluorescent in situ hybridization(FISH). PCyR: 1 to 35% Ph+ cells. MMR: &lt;=0.1% BCR-ABL1 on the IS with at least 10,000 ABL1 transcripts assessed by central laboratory.</description>
          <population>Evaluable set cytogenetic response: treated participants with valid baseline efficacy assessment (&gt;= 20 metaphases from baseline bone marrow or CCyR with &gt;=200 cells from FISH or baseline MMR). Data for this outcome measure was not planned to be collected and analyzed for AP CML and Ph-participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.2" lower_limit="46.5" upper_limit="76.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Cumulative Confirmed Overall Hematological Response (OHR) in Accelerated Phase (AP) Chronic Myelogenous Leukemia (CML) Participants</title>
        <description>Confirmed OHR was defined as complete hematological response (CHR) or return to chronic phase (RCP) by 1 year in AP and BP participants. CHR was defined as white blood cells (WBC) &lt;10*10^9/L, peripheral blood basophils &lt;5%, no peripheral blood myelocytes, promyelocytes, myeloblasts in the differential, platelet count &lt;450*10^9/L, spleen not palpable. Hematologic responses must be of &gt;=4 weeks duration confirmed by 2 assessments &gt;=4 weeks apart.</description>
        <time_frame>Up to 1 year (52 weeks)</time_frame>
        <population>Evaluable set for hematological response: treated participants with a valid baseline hematologic assessment. Data for this outcome measure was not planned to be collected and analyzed for CP2L, CP3L, CP4L and Ph- CML participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Cumulative Confirmed Overall Hematological Response (OHR) in Accelerated Phase (AP) Chronic Myelogenous Leukemia (CML) Participants</title>
          <description>Confirmed OHR was defined as complete hematological response (CHR) or return to chronic phase (RCP) by 1 year in AP and BP participants. CHR was defined as white blood cells (WBC) &lt;10*10^9/L, peripheral blood basophils &lt;5%, no peripheral blood myelocytes, promyelocytes, myeloblasts in the differential, platelet count &lt;450*10^9/L, spleen not palpable. Hematologic responses must be of &gt;=4 weeks duration confirmed by 2 assessments &gt;=4 weeks apart.</description>
          <population>Evaluable set for hematological response: treated participants with a valid baseline hematologic assessment. Data for this outcome measure was not planned to be collected and analyzed for CP2L, CP3L, CP4L and Ph- CML participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0" lower_limit="19.4" upper_limit="99.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Cumulative Major Cytogenetic Response (MCyR)</title>
        <description>CyR was based on prevalence of Ph+ cells. CCyR was achieved when there was 0 % Ph+ cells from &gt;=20 metaphases from conventional bone marrow cytogenetics or &lt;1% Ph+ cells from &gt;=200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present. MCyR was categorized as either CCyR or PCyR. Participants with MMR or better at baseline were counted as CCyR if baseline response was maintained or improved while on treatment.</description>
        <time_frame>Up to 4 years</time_frame>
        <population>Evaluable set cytogenetic response: treated participants with valid baseline efficacy assessment (&gt;=20 metaphases from baseline bone marrow or CCyR with &gt;=200 cells from FISH or baseline MMR). Data for this outcome measure was not planned to be collected and analyzed for Ph- participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Bosutinib: Chronic Phase 2nd Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic phase 2nd line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O2">
            <title>Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O3">
            <title>Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O4">
            <title>Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Cumulative Major Cytogenetic Response (MCyR)</title>
          <description>CyR was based on prevalence of Ph+ cells. CCyR was achieved when there was 0 % Ph+ cells from &gt;=20 metaphases from conventional bone marrow cytogenetics or &lt;1% Ph+ cells from &gt;=200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present. MCyR was categorized as either CCyR or PCyR. Participants with MMR or better at baseline were counted as CCyR if baseline response was maintained or improved while on treatment.</description>
          <population>Evaluable set cytogenetic response: treated participants with valid baseline efficacy assessment (&gt;=20 metaphases from baseline bone marrow or CCyR with &gt;=200 cells from FISH or baseline MMR). Data for this outcome measure was not planned to be collected and analyzed for Ph- participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="45"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.4" lower_limit="74.9" upper_limit="96.1"/>
                    <measurement group_id="O2" value="85.5" lower_limit="73.3" upper_limit="93.5"/>
                    <measurement group_id="O3" value="77.8" lower_limit="62.9" upper_limit="88.8"/>
                    <measurement group_id="O4" value="75.0" lower_limit="19.4" upper_limit="99.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Cumulative Confirmed Overall Hematological Response (OHR) in Participants With Accelerated Phase (AP) Chronic Myelogenous Leukemia (CML)</title>
        <description>Confirmed OHR was defined as CHR or RCP in AP and BP participants. CHR was defined as WBC &lt;10*10^9/L, peripheral blood basophils &lt;5%, no peripheral blood myelocytes, promyelocytes, myeloblasts in the differential, platelet count &lt;450*10^9/L, spleen not palpable. Hematologic responses must be of &gt;=4 weeks duration confirmed by 2 assessments &gt;=4 weeks apart.</description>
        <time_frame>Up to 4 years</time_frame>
        <population>Evaluable set for hematological response: treated participants with a valid baseline hematologic assessment. Data for this outcome measure was not planned to be collected and analyzed for CP2L, CP3L, CP4L and Ph- CML participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Cumulative Confirmed Overall Hematological Response (OHR) in Participants With Accelerated Phase (AP) Chronic Myelogenous Leukemia (CML)</title>
          <description>Confirmed OHR was defined as CHR or RCP in AP and BP participants. CHR was defined as WBC &lt;10*10^9/L, peripheral blood basophils &lt;5%, no peripheral blood myelocytes, promyelocytes, myeloblasts in the differential, platelet count &lt;450*10^9/L, spleen not palpable. Hematologic responses must be of &gt;=4 weeks duration confirmed by 2 assessments &gt;=4 weeks apart.</description>
          <population>Evaluable set for hematological response: treated participants with a valid baseline hematologic assessment. Data for this outcome measure was not planned to be collected and analyzed for CP2L, CP3L, CP4L and Ph- CML participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0" lower_limit="19.4" upper_limit="99.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Cumulative Best Response</title>
        <description>Hierarchy best response: %participants with best response among molecular/cytogenetic/hematologic response. Molecular response:MR4.5/MR4/MMR defined as &lt;=0.0032/0.01/0.1% BCR-ABL1 ratio on IS corresponding to &gt;=4.5/4/3-log reduction from standardised baseline with at least 32,000/10,000/10,000 ABL1 assessed by central laboratory. CyR:based on prevalence of Ph+cells. CCyR: 0% Ph+cells from &gt;=20 metaphases from conventional cytogenetics or &lt;1%Ph+cells from &gt;=200 cells from FISH. PCyR:1 to 35% Ph+cells. CHR:WBC &lt;10*10^9/L, peripheral blood basophils&lt;5%, no peripheral blood myelocytes, promyelocytes, myeloblasts in differential, platelet count&lt;450*10^9/L, spleen not palpable.</description>
        <time_frame>Up to 4 years</time_frame>
        <population>Evaluable set:treated participants with valid baseline molecular, cytogenetic or hematologic assessment. Data for this outcome measure (all categories including OHR) was not planned to be collected and analyzed for Ph- CML participants. Data for OHR was not planned to be collected and analyzed for CP CML participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Bosutinib: Chronic Phase 2nd Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic phase 2nd line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O2">
            <title>Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O3">
            <title>Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O4">
            <title>Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Cumulative Best Response</title>
          <description>Hierarchy best response: %participants with best response among molecular/cytogenetic/hematologic response. Molecular response:MR4.5/MR4/MMR defined as &lt;=0.0032/0.01/0.1% BCR-ABL1 ratio on IS corresponding to &gt;=4.5/4/3-log reduction from standardised baseline with at least 32,000/10,000/10,000 ABL1 assessed by central laboratory. CyR:based on prevalence of Ph+cells. CCyR: 0% Ph+cells from &gt;=20 metaphases from conventional cytogenetics or &lt;1%Ph+cells from &gt;=200 cells from FISH. PCyR:1 to 35% Ph+cells. CHR:WBC &lt;10*10^9/L, peripheral blood basophils&lt;5%, no peripheral blood myelocytes, promyelocytes, myeloblasts in differential, platelet count&lt;450*10^9/L, spleen not palpable.</description>
          <population>Evaluable set:treated participants with valid baseline molecular, cytogenetic or hematologic assessment. Data for this outcome measure (all categories including OHR) was not planned to be collected and analyzed for Ph- CML participants. Data for OHR was not planned to be collected and analyzed for CP CML participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="61"/>
                <count group_id="O3" value="49"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MR4.5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="61"/>
                    <count group_id="O3" value="49"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.4" lower_limit="7.8" upper_limit="31.4"/>
                    <measurement group_id="O2" value="14.8" lower_limit="7.0" upper_limit="26.2"/>
                    <measurement group_id="O3" value="8.2" lower_limit="2.3" upper_limit="19.6"/>
                    <measurement group_id="O4" value="25.0" lower_limit="0.6" upper_limit="80.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MR4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="61"/>
                    <count group_id="O3" value="49"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.2" lower_limit="6.3" upper_limit="28.9"/>
                    <measurement group_id="O2" value="11.5" lower_limit="4.7" upper_limit="22.2"/>
                    <measurement group_id="O3" value="6.1" lower_limit="1.3" upper_limit="16.9"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="60.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MMR</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="61"/>
                    <count group_id="O3" value="49"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7" lower_limit="2.4" upper_limit="20.8"/>
                    <measurement group_id="O2" value="11.5" lower_limit="4.7" upper_limit="22.2"/>
                    <measurement group_id="O3" value="14.3" lower_limit="5.9" upper_limit="27.2"/>
                    <measurement group_id="O4" value="25.0" lower_limit="0.6" upper_limit="80.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CCyR</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="61"/>
                    <count group_id="O3" value="49"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" lower_limit="0.1" upper_limit="11.5"/>
                    <measurement group_id="O2" value="13.1" lower_limit="5.8" upper_limit="24.2"/>
                    <measurement group_id="O3" value="14.3" lower_limit="5.9" upper_limit="27.2"/>
                    <measurement group_id="O4" value="25.0" lower_limit="0.6" upper_limit="80.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PCyR</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="61"/>
                    <count group_id="O3" value="49"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" lower_limit="0.1" upper_limit="11.5"/>
                    <measurement group_id="O2" value="1.6" lower_limit="0.0" upper_limit="8.8"/>
                    <measurement group_id="O3" value="4.1" lower_limit="0.5" upper_limit="14.0"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="60.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CHR</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="61"/>
                    <count group_id="O3" value="49"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.9" lower_limit="3.6" upper_limit="23.6"/>
                    <measurement group_id="O2" value="8.2" lower_limit="2.7" upper_limit="18.1"/>
                    <measurement group_id="O3" value="16.3" lower_limit="7.3" upper_limit="29.7"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="60.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>OHR</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="60.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Major Cytogenetic Response (MCyR) at Months 3, 6, 12, 18 and 24</title>
        <description>CyR was based on prevalence of Ph+ cells. CCyR was achieved when there was 0 % Ph+ cells from &gt;=20 metaphases from conventional bone marrow cytogenetics or &lt;1% Ph+ cells from &gt;=200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present. MCyR was categorized as either CCyR or PCyR. Participants with MMR or better at baseline were counted as CCyR if baseline response was maintained or improved while on treatment.</description>
        <time_frame>Months 3, 6, 12, 18, and 24</time_frame>
        <population>Evaluable set cytogenetic response: treated participants with valid baseline efficacy assessment (&gt;= 20 metaphases from baseline bone marrow or CCyR with &gt;=200 cells from FISH or baseline MMR). Data for this outcome measure was not planned to be collected and analyzed for Ph- participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Bosutinib: Chronic Phase 2nd Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic phase 2nd line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O2">
            <title>Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O3">
            <title>Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O4">
            <title>Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Major Cytogenetic Response (MCyR) at Months 3, 6, 12, 18 and 24</title>
          <description>CyR was based on prevalence of Ph+ cells. CCyR was achieved when there was 0 % Ph+ cells from &gt;=20 metaphases from conventional bone marrow cytogenetics or &lt;1% Ph+ cells from &gt;=200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present. MCyR was categorized as either CCyR or PCyR. Participants with MMR or better at baseline were counted as CCyR if baseline response was maintained or improved while on treatment.</description>
          <population>Evaluable set cytogenetic response: treated participants with valid baseline efficacy assessment (&gt;= 20 metaphases from baseline bone marrow or CCyR with &gt;=200 cells from FISH or baseline MMR). Data for this outcome measure was not planned to be collected and analyzed for Ph- participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="45"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At 3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.4" lower_limit="66.6" upper_limit="91.6"/>
                    <measurement group_id="O2" value="80.0" lower_limit="67.0" upper_limit="89.6"/>
                    <measurement group_id="O3" value="55.6" lower_limit="40.0" upper_limit="70.4"/>
                    <measurement group_id="O4" value="75.0" lower_limit="19.4" upper_limit="99.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.8" lower_limit="53.9" upper_limit="82.8"/>
                    <measurement group_id="O2" value="63.6" lower_limit="49.6" upper_limit="76.2"/>
                    <measurement group_id="O3" value="62.2" lower_limit="46.5" upper_limit="76.2"/>
                    <measurement group_id="O4" value="25.0" lower_limit="0.6" upper_limit="80.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.8" lower_limit="53.9" upper_limit="82.8"/>
                    <measurement group_id="O2" value="65.5" lower_limit="51.4" upper_limit="77.8"/>
                    <measurement group_id="O3" value="48.9" lower_limit="33.7" upper_limit="64.2"/>
                    <measurement group_id="O4" value="25.0" lower_limit="0.6" upper_limit="80.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 18 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.4" lower_limit="51.5" upper_limit="80.9"/>
                    <measurement group_id="O2" value="63.6" lower_limit="49.6" upper_limit="76.2"/>
                    <measurement group_id="O3" value="42.2" lower_limit="27.7" upper_limit="57.8"/>
                    <measurement group_id="O4" value="25.0" lower_limit="0.6" upper_limit="80.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 24 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.4" lower_limit="51.5" upper_limit="80.9"/>
                    <measurement group_id="O2" value="54.5" lower_limit="40.6" upper_limit="68.0"/>
                    <measurement group_id="O3" value="44.4" lower_limit="29.6" upper_limit="60.0"/>
                    <measurement group_id="O4" value="25.0" lower_limit="0.6" upper_limit="80.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Accelerated Phase Participants With Confirmed Overall Hematological Response (OHR) at Month 3, 6, 9, 12, 18, and 24</title>
        <description>Confirmed OHR was defined as CHR or RCP in AP and BP participants. CHR was defined as WBC &lt;10*10^9/L, peripheral blood basophils &lt;5%, no peripheral blood myelocytes, promyelocytes, myeloblasts in the differential, platelet count &lt;450*10^9/L, spleen not palpable. Hematologic responses must be of &gt;=4 weeks duration confirmed by 2 assessments &gt;=4 weeks apart.</description>
        <time_frame>Months 3, 6, 9, 12, 18, and 24</time_frame>
        <population>Evaluable set hematological response: treated participants with a valid baseline hematologic assessment. Data for this outcome measure was not planned to be collected and analyzed for CP2L, CP3L, CP4L and Ph- CML participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Accelerated Phase Participants With Confirmed Overall Hematological Response (OHR) at Month 3, 6, 9, 12, 18, and 24</title>
          <description>Confirmed OHR was defined as CHR or RCP in AP and BP participants. CHR was defined as WBC &lt;10*10^9/L, peripheral blood basophils &lt;5%, no peripheral blood myelocytes, promyelocytes, myeloblasts in the differential, platelet count &lt;450*10^9/L, spleen not palpable. Hematologic responses must be of &gt;=4 weeks duration confirmed by 2 assessments &gt;=4 weeks apart.</description>
          <population>Evaluable set hematological response: treated participants with a valid baseline hematologic assessment. Data for this outcome measure was not planned to be collected and analyzed for CP2L, CP3L, CP4L and Ph- CML participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At 3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0" lower_limit="19.4" upper_limit="99.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" lower_limit="6.8" upper_limit="93.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 9 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0" lower_limit="19.4" upper_limit="99.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0" lower_limit="19.4" upper_limit="99.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 18 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0" lower_limit="0.6" upper_limit="80.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 24 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="60.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Cumulative Confirmed Complete Hematological Response (CHR)</title>
        <description>CHR was defined as WBC &lt;10*10^9/L, peripheral blood basophils &lt;5%, no peripheral blood myelocytes, promyelocytes, myeloblasts in the differential, platelet count &lt;450*10^9/L, spleen not palpable. Hematologic responses must be of &gt;=4 weeks duration confirmed by 2 assessments &gt;=4 weeks apart.</description>
        <time_frame>Up to 4 years</time_frame>
        <population>Evaluable set for hematological response: treated participants with a valid baseline hematologic assessment. Data for this outcome measure was not planned to be collected and analyzed for Ph- participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Bosutinib: Chronic Phase 2nd Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic phase 2nd line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O2">
            <title>Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O3">
            <title>Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O4">
            <title>Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Cumulative Confirmed Complete Hematological Response (CHR)</title>
          <description>CHR was defined as WBC &lt;10*10^9/L, peripheral blood basophils &lt;5%, no peripheral blood myelocytes, promyelocytes, myeloblasts in the differential, platelet count &lt;450*10^9/L, spleen not palpable. Hematologic responses must be of &gt;=4 weeks duration confirmed by 2 assessments &gt;=4 weeks apart.</description>
          <population>Evaluable set for hematological response: treated participants with a valid baseline hematologic assessment. Data for this outcome measure was not planned to be collected and analyzed for Ph- participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="61"/>
                <count group_id="O3" value="48"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.3" lower_limit="79.2" upper_limit="97.6"/>
                    <measurement group_id="O2" value="82.0" lower_limit="70.0" upper_limit="90.6"/>
                    <measurement group_id="O3" value="77.1" lower_limit="62.7" upper_limit="88.0"/>
                    <measurement group_id="O4" value="75.0" lower_limit="19.4" upper_limit="99.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Cumulative Major Molecular Response (MMR)</title>
        <description>Molecular response: MR4.5/MR4/MMR defined as &lt;=0.0032/0.01/0.1% BCR-ABL1 ratio respectively, on IS corresponding to &gt;=4.5/4/3-log reduction from standardized baseline with at least 32,000/10,000/10,000 ABL1 assessed by central laboratory. To be considered a responder, the participant must have had maintenance of baseline response while on-treatment or an improvement from baseline.</description>
        <time_frame>Up to 4 years</time_frame>
        <population>Evaluable set for molecular response: treated participants with a valid baseline molecular assessment. Data for this outcome measure was not planned to be collected and analyzed for Ph- participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Bosutinib: Chronic Phase 2nd Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic phase 2nd line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O2">
            <title>Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O3">
            <title>Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O4">
            <title>Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Cumulative Major Molecular Response (MMR)</title>
          <description>Molecular response: MR4.5/MR4/MMR defined as &lt;=0.0032/0.01/0.1% BCR-ABL1 ratio respectively, on IS corresponding to &gt;=4.5/4/3-log reduction from standardized baseline with at least 32,000/10,000/10,000 ABL1 assessed by central laboratory. To be considered a responder, the participant must have had maintenance of baseline response while on-treatment or an improvement from baseline.</description>
          <population>Evaluable set for molecular response: treated participants with a valid baseline molecular assessment. Data for this outcome measure was not planned to be collected and analyzed for Ph- participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="48"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MMR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.6" lower_limit="68.6" upper_limit="92.2"/>
                    <measurement group_id="O2" value="76.4" lower_limit="63.0" upper_limit="86.8"/>
                    <measurement group_id="O3" value="56.3" lower_limit="41.2" upper_limit="70.5"/>
                    <measurement group_id="O4" value="50.0" lower_limit="6.8" upper_limit="93.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MR4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.9" lower_limit="58.9" upper_limit="85.7"/>
                    <measurement group_id="O2" value="63.6" lower_limit="49.6" upper_limit="76.2"/>
                    <measurement group_id="O3" value="41.7" lower_limit="27.6" upper_limit="56.8"/>
                    <measurement group_id="O4" value="25.0" lower_limit="0.6" upper_limit="80.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MR4.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.7" lower_limit="43.2" upper_limit="73.0"/>
                    <measurement group_id="O2" value="50.9" lower_limit="37.1" upper_limit="64.6"/>
                    <measurement group_id="O3" value="35.4" lower_limit="22.2" upper_limit="50.5"/>
                    <measurement group_id="O4" value="25.0" lower_limit="0.6" upper_limit="80.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Kaplan-Meier Estimate of Probability of Retaining Complete Cytogenetic Response (CCyR) at Month 36</title>
        <description>Kaplan-Meier analysis. Duration of CCyR: from first date of CCyR to date of confirmed loss of CCyR/disease progression/on-treatment death or censoring, analyzed for responders only. CyR: prevalence of Ph+ cells. CCyR: 0% Ph+ cells from &gt;=20 metaphases from conventional cytogenetics or &lt;1% Ph+ cells from &gt;=200 cells analyzed by FISH or MMR (&lt;=0.1% BCR-ABL1 on the IS with at least 10,000 ABL1 transcripts assessed by central laboratory). Confirmed loss: 2 consecutive non-response assessments &gt;=28 days apart. Progression: for CP: participants evolving from CP to AP, loss of CHR; loss of MCyR; in participants without CHR WBC &gt;20*10^9/L on 2 occasions &gt;=2 weeks apart after the first 4 weeks of treatment; for AP: confirmed BP, loss of previous hematologic response over a 2-week period, loss of CHR, no decrease from baseline levels (if considered clinically relevant) in percentage blasts in peripheral blood or bone marrow on all assessments over a 4-week period.</description>
        <time_frame>At Month 36</time_frame>
        <population>Evaluable set for cytogenetic response: treated participants with valid baseline cytogenetic assessment (&gt;= 20 metaphases from baseline bone marrow or CCyR with &gt;=200 cells from FISH or baseline MMR) and who achieved CCyR. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure who had CCyR.</population>
        <group_list>
          <group group_id="O1">
            <title>Bosutinib: Chronic Phase 2nd Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic phase 2nd line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O2">
            <title>Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O3">
            <title>Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O4">
            <title>Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.</description>
          </group>
        </group_list>
        <measure>
          <title>Kaplan-Meier Estimate of Probability of Retaining Complete Cytogenetic Response (CCyR) at Month 36</title>
          <description>Kaplan-Meier analysis. Duration of CCyR: from first date of CCyR to date of confirmed loss of CCyR/disease progression/on-treatment death or censoring, analyzed for responders only. CyR: prevalence of Ph+ cells. CCyR: 0% Ph+ cells from &gt;=20 metaphases from conventional cytogenetics or &lt;1% Ph+ cells from &gt;=200 cells analyzed by FISH or MMR (&lt;=0.1% BCR-ABL1 on the IS with at least 10,000 ABL1 transcripts assessed by central laboratory). Confirmed loss: 2 consecutive non-response assessments &gt;=28 days apart. Progression: for CP: participants evolving from CP to AP, loss of CHR; loss of MCyR; in participants without CHR WBC &gt;20*10^9/L on 2 occasions &gt;=2 weeks apart after the first 4 weeks of treatment; for AP: confirmed BP, loss of previous hematologic response over a 2-week period, loss of CHR, no decrease from baseline levels (if considered clinically relevant) in percentage blasts in peripheral blood or bone marrow on all assessments over a 4-week period.</description>
          <population>Evaluable set for cytogenetic response: treated participants with valid baseline cytogenetic assessment (&gt;= 20 metaphases from baseline bone marrow or CCyR with &gt;=200 cells from FISH or baseline MMR) and who achieved CCyR. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure who had CCyR.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="33"/>
                <count group_id="O4" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.4" lower_limit="77.2" upper_limit="99.5"/>
                    <measurement group_id="O2" value="94.4" lower_limit="79.2" upper_limit="98.6"/>
                    <measurement group_id="O3" value="100.0" lower_limit="100.0" upper_limit="100.0"/>
                    <measurement group_id="O4" value="100.0" lower_limit="100.0" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Kaplan-Meier Estimate of Probability of Retaining Major Molecular Response (MMR) at Month 36</title>
        <description>Kaplan-Meier analysis. Duration of MMR: from first date of MMR to confirmed loss of MMR/disease progression/on-treatment death or censoring, analyzed for responders only. MMR:&lt;=0.1% BCR-ABL1 on the IS with at least 10,000 ABL1 transcripts assessed by central laboratory . Confirmed loss: 2 consecutive non-response assessments &gt;=28 days apart with a &lt;3-log (&gt;0.1%) reduction in transcripts one of which corresponds to a &lt;=2-log reduction (&gt;=1%). Progression: for CP: participants evolving from CP to AP, loss of CHR; loss of MCyR; in participants without CHR WBC &gt;20*10^9/L on 2 occasions &gt;=2weeks apart after the first 4 weeks of treatment; for AP: confirmed BP, loss of previous hematologic response over a 2-week period, loss of CHR, no decrease from baseline levels (if considered clinically relevant) in percentage blasts in peripheral blood or bone marrow on all assessments over a 4-week period.</description>
        <time_frame>At Month 36</time_frame>
        <population>Evaluable set for molecular response: treated participants with valid baseline molecular assessment and who achieved MMR. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure who had MMR.</population>
        <group_list>
          <group group_id="O1">
            <title>Bosutinib: Chronic Phase 2nd Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic phase 2nd line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O2">
            <title>Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O3">
            <title>Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O4">
            <title>Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.</description>
          </group>
        </group_list>
        <measure>
          <title>Kaplan-Meier Estimate of Probability of Retaining Major Molecular Response (MMR) at Month 36</title>
          <description>Kaplan-Meier analysis. Duration of MMR: from first date of MMR to confirmed loss of MMR/disease progression/on-treatment death or censoring, analyzed for responders only. MMR:&lt;=0.1% BCR-ABL1 on the IS with at least 10,000 ABL1 transcripts assessed by central laboratory . Confirmed loss: 2 consecutive non-response assessments &gt;=28 days apart with a &lt;3-log (&gt;0.1%) reduction in transcripts one of which corresponds to a &lt;=2-log reduction (&gt;=1%). Progression: for CP: participants evolving from CP to AP, loss of CHR; loss of MCyR; in participants without CHR WBC &gt;20*10^9/L on 2 occasions &gt;=2weeks apart after the first 4 weeks of treatment; for AP: confirmed BP, loss of previous hematologic response over a 2-week period, loss of CHR, no decrease from baseline levels (if considered clinically relevant) in percentage blasts in peripheral blood or bone marrow on all assessments over a 4-week period.</description>
          <population>Evaluable set for molecular response: treated participants with valid baseline molecular assessment and who achieved MMR. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure who had MMR.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="27"/>
                <count group_id="O4" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.7" lower_limit="73.9" upper_limit="96.9"/>
                    <measurement group_id="O2" value="81.5" lower_limit="63.2" upper_limit="91.3"/>
                    <measurement group_id="O3" value="90.2" lower_limit="65.9" upper_limit="97.5"/>
                    <measurement group_id="O4" value="100.0" lower_limit="100.0" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs</title>
        <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAE: any event increasing in severity from baseline or any new event started during bosutinib therapy or within 28 days of the last dose of study drug. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly.</description>
        <time_frame>First dose of study drug up to 28 days after last dose (up to maximum of 4 years)</time_frame>
        <population>The safety analysis set included participants who received at least 1 dose of bosutinib.</population>
        <group_list>
          <group group_id="O1">
            <title>Bosutinib: Chronic Phase 2nd Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic phase 2nd line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O2">
            <title>Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O3">
            <title>Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O4">
            <title>Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O5">
            <title>Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia</title>
            <description>Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O6">
            <title>Bosutinib: Chronic Myelogenous Leukemia</title>
            <description>Participants with Philadelphia chromosome positive chronic phase 2nd, 3rd and 4th line chronic myelogenous leukemia, Philadelphia chromosome positive accelerated phase chronic myelogenous leukemia and BCR-ABL1-chronic myelogenous leukemia/Philadelphia chromosome negative chronic myelogenous leukemia.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs</title>
          <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAE: any event increasing in severity from baseline or any new event started during bosutinib therapy or within 28 days of the last dose of study drug. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly.</description>
          <population>The safety analysis set included participants who received at least 1 dose of bosutinib.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="61"/>
                <count group_id="O3" value="49"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="3"/>
                <count group_id="O6" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="61"/>
                    <measurement group_id="O3" value="48"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-emergent SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Grade 3 or 4 Treatment Emergent Adverse Events (TEAEs) Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0</title>
        <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAE was any event increasing in severity from baseline or any new event that started during bosutinib therapy or within 28 days of the last dose of study drug. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Number of participants with Grade 3 or 4 TEAEs are reported.</description>
        <time_frame>First dose of study drug up to 28 days after last dose (up to maximum of 4 years)</time_frame>
        <population>The safety analysis set included participants who received at least 1 dose of bosutinib.</population>
        <group_list>
          <group group_id="O1">
            <title>Bosutinib: Chronic Phase 2nd Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic phase 2nd line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O2">
            <title>Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O3">
            <title>Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O4">
            <title>Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O5">
            <title>Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia</title>
            <description>Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O6">
            <title>Bosutinib: Chronic Myelogenous Leukemia</title>
            <description>Participants with Philadelphia chromosome positive chronic phase 2nd, 3rd and 4th line chronic myelogenous leukemia, Philadelphia chromosome positive accelerated phase chronic myelogenous leukemia and BCR-ABL1-chronic myelogenous leukemia/Philadelphia chromosome negative chronic myelogenous leukemia.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Grade 3 or 4 Treatment Emergent Adverse Events (TEAEs) Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0</title>
          <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAE was any event increasing in severity from baseline or any new event that started during bosutinib therapy or within 28 days of the last dose of study drug. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Number of participants with Grade 3 or 4 TEAEs are reported.</description>
          <population>The safety analysis set included participants who received at least 1 dose of bosutinib.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="61"/>
                <count group_id="O3" value="49"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="3"/>
                <count group_id="O6" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="49"/>
                    <measurement group_id="O3" value="39"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment Related Treatment Emergent Adverse Events (TEAEs)</title>
        <description>An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAE was any event increasing in severity from baseline or any new event that started during bosutinib therapy or within 28 days of the last dose of study drug. Relatedness to drug was assessed by investigator.</description>
        <time_frame>First dose of study drug up to 28 days after last dose (up to maximum of 4 years)</time_frame>
        <population>The safety analysis set included participants who received at least 1 dose of bosutinib.</population>
        <group_list>
          <group group_id="O1">
            <title>Bosutinib: Chronic Phase 2nd Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic phase 2nd line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O2">
            <title>Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O3">
            <title>Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O4">
            <title>Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O5">
            <title>Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia</title>
            <description>Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O6">
            <title>Bosutinib: Chronic Myelogenous Leukemia</title>
            <description>Participants with Philadelphia chromosome positive chronic phase 2nd, 3rd and 4th line chronic myelogenous leukemia, Philadelphia chromosome positive accelerated phase chronic myelogenous leukemia and BCR-ABL1-chronic myelogenous leukemia/Philadelphia chromosome negative chronic myelogenous leukemia.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Related Treatment Emergent Adverse Events (TEAEs)</title>
          <description>An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAE was any event increasing in severity from baseline or any new event that started during bosutinib therapy or within 28 days of the last dose of study drug. Relatedness to drug was assessed by investigator.</description>
          <population>The safety analysis set included participants who received at least 1 dose of bosutinib.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="61"/>
                <count group_id="O3" value="49"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="3"/>
                <count group_id="O6" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="61"/>
                    <measurement group_id="O3" value="48"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Laboratory Abnormalities Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03</title>
        <description>Number of participants with any hematological, chemistry and coagulation abnormality of any grade were reported. Hematological: absolute neutrophil count (low), hemoglobin (low), lymphocytes (low), platelets (low) and leukocytes (low). Chemistry: alkaline phosphatase (high), alanine aminotransferase (high), amylase (high), aspartate aminotransferase (high), bilirubin (high), creatinine (high), lipase (high). Coagulation: activated partial prothrombin time (low), prothrombin time (low and high), partial prothrombin time (high).</description>
        <time_frame>First dose of study drug up to 28 days after last dose (up to maximum of 4 years)</time_frame>
        <population>The safety analysis set included participants who received at least 1 dose of bosutinib.</population>
        <group_list>
          <group group_id="O1">
            <title>Bosutinib: Chronic Phase 2nd Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic phase 2nd line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O2">
            <title>Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O3">
            <title>Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O4">
            <title>Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia</title>
            <description>Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O5">
            <title>Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia</title>
            <description>Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia.</description>
          </group>
          <group group_id="O6">
            <title>Bosutinib: Chronic Myelogenous Leukemia</title>
            <description>Participants with Philadelphia chromosome positive chronic phase 2nd, 3rd and 4th line chronic myelogenous leukemia, Philadelphia chromosome positive accelerated phase chronic myelogenous leukemia and BCR-ABL1-chronic myelogenous leukemia/Philadelphia chromosome negative chronic myelogenous leukemia.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Laboratory Abnormalities Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03</title>
          <description>Number of participants with any hematological, chemistry and coagulation abnormality of any grade were reported. Hematological: absolute neutrophil count (low), hemoglobin (low), lymphocytes (low), platelets (low) and leukocytes (low). Chemistry: alkaline phosphatase (high), alanine aminotransferase (high), amylase (high), aspartate aminotransferase (high), bilirubin (high), creatinine (high), lipase (high). Coagulation: activated partial prothrombin time (low), prothrombin time (low and high), partial prothrombin time (high).</description>
          <population>The safety analysis set included participants who received at least 1 dose of bosutinib.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="61"/>
                <count group_id="O3" value="49"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="3"/>
                <count group_id="O6" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hematology</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="56"/>
                    <measurement group_id="O3" value="40"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chemistry</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="61"/>
                    <measurement group_id="O3" value="49"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="163"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Coagulation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)</time_frame>
      <desc>The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.</desc>
      <group_list>
        <group group_id="E1">
          <title>Bosutinib: Chronic Phase 2nd Line Chronic Myelogenous Leukemia</title>
          <description>Participants with philadelphia chromosome positive chronic phase 2nd line chronic myelogenous leukemia.</description>
        </group>
        <group group_id="E2">
          <title>Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia</title>
          <description>Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.</description>
        </group>
        <group group_id="E3">
          <title>Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia</title>
          <description>Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.</description>
        </group>
        <group group_id="E4">
          <title>Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia</title>
          <description>Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.</description>
        </group>
        <group group_id="E5">
          <title>Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia</title>
          <description>Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia.</description>
        </group>
        <group group_id="E6">
          <title>Bosutinib: Chronic Myelogenous Leukemia</title>
          <description>Participants with Philadelphia chromosome positive chronic phase 2nd, 3rd and 4th line chronic myelogenous leukemia, Philadelphia chromosome positive accelerated phase chronic myelogenous leukemia and BCR-ABL1-chronic myelogenous leukemia/Philadelphia chromosome negative chronic myelogenous leukemia.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA v23.1</default_vocab>
        <default_assessment>Non-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="5" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="19" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="69" subjects_at_risk="163"/>
              </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="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Abdominal lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Bundle branch block right</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Cardiogenic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Cardiomyopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Coronary artery occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Sinus node dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Keratoconus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </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="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Appendiceal mucocoele</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Hiatus hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Oesophageal fistula</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Rectal polyp</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Subileus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Hepatic cirrhosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pneumonia pneumococcal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pseudomembranous colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arterial restenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Fluid retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Metabolic disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Anaplastic large-cell lymphoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Brain neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Laryngeal squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Lymphoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Metastases to liver</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of lung</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Breast mass</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Ovarian cyst ruptured</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Emphysema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Lung disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pulmonary hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Peripheral ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Shock haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA v23.1</default_vocab>
        <default_assessment>Non-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="46" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="61" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="48" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="162" subjects_at_risk="163"/>
              </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="7" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="28" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="19" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Conjunctival hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="54" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="42" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="145" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="25" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="70" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="55" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="49" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="37" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="32" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="14" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="11" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="46" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="36" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="31" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="29" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="26" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="14" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="15" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="44" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="33" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="26" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="25" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="16" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="14" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyl transferase increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="13" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Blood uric acid increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Blood folate decreased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="163"/>
              </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="4" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="23" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="163"/>
              </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="8" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="37" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="23" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="22" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="13" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Intervertebral disc disorder</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="29" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="11" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="47" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="27" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="11" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="39" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="31" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="29" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="11" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="18" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="13" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="13" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="25" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="15" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="163"/>
              </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>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer Inc.</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.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/NCT02228382
org study id: B1871039
secondary id: 2013-003250-25
secondary id: BYOND
nct id: NCT02228382
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to fulfill the post-authorization commitment made by Pfizer to
      the European Medicines Agency in providing additional safety and efficacy data in
      approximately 150 Philadelphia Chromosome Positive Chronic Myeloid Leukemia patients with
      high unmet medical need, including 75 Chronic Phase, Accelerated Phase or Blast Phase
      patients in the fourth or later line treatment setting (i.e., after treatment with at least 3
      other Tyrosine Kinase Inhibitors).
allocation: N/A
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Cumulative Confirmed Major Cytogenetic Response (MCyR) in 2nd and 3rd Line Chronic Phase (CP) Participants
time frame: Up to 1 year (52 weeks)
description: Confirmed MCyR: confirmed (complete cytogenetic response[CCyR] or partial cytogenetic response[PCyR]) by 1 year for participants entering the study without CCyR or maintenance of confirmed CCyR for at least 1 year after treatment start with bosutinib for participants entering the study with CCyR or at least major molecular response(MMR) by 1 year and a deeper molecular response compared to baseline. Participants with baseline PCyR that did not achieve CCyR were counted as nonresponders. Initial cytogenetic (in absence of MMR) responses must have been confirmed by 2 consecutive assessments >=28 days apart. CCyR: 0% Ph+ cells from >=20 metaphases from conventional cytogenetics or <1% Ph+ cells from >= 200 cells from fluorescent in situ hybridization(FISH). PCyR: 1 to 35% Ph+ cells. MMR: <=0.1% BCR-ABL1 on the international scale (IS) with at least 10,000 ABL1 transcripts assessed by central laboratory.
measure: Percentage of Participants With Cumulative Confirmed Major Cytogenetic Response (MCyR) in 4th or Later Line Chronic Phase (CP) Participants
time frame: Up to 1 year (52 weeks)
description: Confirmed MCyR: confirmed CCyR or PCyR by 1 year for participants entering the study without CCyR or maintenance of confirmed CCyR for at least 1 year after treatment start with bosutinib for participants entering the study with CCyR or at least MMR by 1 year and a deeper molecular response compared to baseline. Participants with baseline PCyR that did not achieve CCyR were counted as nonresponders. Initial cytogenetic (in absence of MMR) responses must have been confirmed by 2 consecutive assessments >=28 days apart. CCyR: 0% Ph+ cells from >=20 metaphases from conventional cytogenetics or <1% Ph+ cells from >= 200 cells from fluorescent in situ hybridization(FISH). PCyR: 1 to 35% Ph+ cells. MMR: <=0.1% BCR-ABL1 on the IS with at least 10,000 ABL1 transcripts assessed by central laboratory.
measure: Percentage of Participants With Cumulative Confirmed Overall Hematological Response (OHR) in Accelerated Phase (AP) Chronic Myelogenous Leukemia (CML) Participants
time frame: Up to 1 year (52 weeks)
description: Confirmed OHR was defined as complete hematological response (CHR) or return to chronic phase (RCP) by 1 year in AP and BP participants. CHR was defined as white blood cells (WBC) <10*10^9/L, peripheral blood basophils <5%, no peripheral blood myelocytes, promyelocytes, myeloblasts in the differential, platelet count <450*10^9/L, spleen not palpable. Hematologic responses must be of >=4 weeks duration confirmed by 2 assessments >=4 weeks apart.
measure: Percentage of Participants With Cumulative Major Cytogenetic Response (MCyR)
time frame: Up to 4 years
description: CyR was based on prevalence of Ph+ cells. CCyR was achieved when there was 0 % Ph+ cells from >=20 metaphases from conventional bone marrow cytogenetics or <1% Ph+ cells from >=200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present. MCyR was categorized as either CCyR or PCyR. Participants with MMR or better at baseline were counted as CCyR if baseline response was maintained or improved while on treatment.
measure: Percentage of Participants With Cumulative Confirmed Overall Hematological Response (OHR) in Participants With Accelerated Phase (AP) Chronic Myelogenous Leukemia (CML)
time frame: Up to 4 years
description: Confirmed OHR was defined as CHR or RCP in AP and BP participants. CHR was defined as WBC <10*10^9/L, peripheral blood basophils <5%, no peripheral blood myelocytes, promyelocytes, myeloblasts in the differential, platelet count <450*10^9/L, spleen not palpable. Hematologic responses must be of >=4 weeks duration confirmed by 2 assessments >=4 weeks apart.
measure: Percentage of Participants With Cumulative Best Response
time frame: Up to 4 years
description: Hierarchy best response: %participants with best response among molecular/cytogenetic/hematologic response. Molecular response:MR4.5/MR4/MMR defined as <=0.0032/0.01/0.1% BCR-ABL1 ratio on IS corresponding to >=4.5/4/3-log reduction from standardised baseline with at least 32,000/10,000/10,000 ABL1 assessed by central laboratory. CyR:based on prevalence of Ph+cells. CCyR: 0% Ph+cells from >=20 metaphases from conventional cytogenetics or <1%Ph+cells from >=200 cells from FISH. PCyR:1 to 35% Ph+cells. CHR:WBC <10*10^9/L, peripheral blood basophils<5%, no peripheral blood myelocytes, promyelocytes, myeloblasts in differential, platelet count<450*10^9/L, spleen not palpable.
measure: Percentage of Participants With Major Cytogenetic Response (MCyR) at Months 3, 6, 12, 18 and 24
time frame: Months 3, 6, 12, 18, and 24
description: CyR was based on prevalence of Ph+ cells. CCyR was achieved when there was 0 % Ph+ cells from >=20 metaphases from conventional bone marrow cytogenetics or <1% Ph+ cells from >=200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present. MCyR was categorized as either CCyR or PCyR. Participants with MMR or better at baseline were counted as CCyR if baseline response was maintained or improved while on treatment.
measure: Percentage of Accelerated Phase Participants With Confirmed Overall Hematological Response (OHR) at Month 3, 6, 9, 12, 18, and 24
time frame: Months 3, 6, 9, 12, 18, and 24
description: Confirmed OHR was defined as CHR or RCP in AP and BP participants. CHR was defined as WBC <10*10^9/L, peripheral blood basophils <5%, no peripheral blood myelocytes, promyelocytes, myeloblasts in the differential, platelet count <450*10^9/L, spleen not palpable. Hematologic responses must be of >=4 weeks duration confirmed by 2 assessments >=4 weeks apart.
measure: Percentage of Participants With Cumulative Confirmed Complete Hematological Response (CHR)
time frame: Up to 4 years
description: CHR was defined as WBC <10*10^9/L, peripheral blood basophils <5%, no peripheral blood myelocytes, promyelocytes, myeloblasts in the differential, platelet count <450*10^9/L, spleen not palpable. Hematologic responses must be of >=4 weeks duration confirmed by 2 assessments >=4 weeks apart.
measure: Percentage of Participants With Cumulative Major Molecular Response (MMR)
time frame: Up to 4 years
description: Molecular response: MR4.5/MR4/MMR defined as <=0.0032/0.01/0.1% BCR-ABL1 ratio respectively, on IS corresponding to >=4.5/4/3-log reduction from standardized baseline with at least 32,000/10,000/10,000 ABL1 assessed by central laboratory. To be considered a responder, the participant must have had maintenance of baseline response while on-treatment or an improvement from baseline.
measure: Kaplan-Meier Estimate of Probability of Retaining Complete Cytogenetic Response (CCyR) at Month 36
time frame: At Month 36
description: Kaplan-Meier analysis. Duration of CCyR: from first date of CCyR to date of confirmed loss of CCyR/disease progression/on-treatment death or censoring, analyzed for responders only. CyR: prevalence of Ph+ cells. CCyR: 0% Ph+ cells from >=20 metaphases from conventional cytogenetics or <1% Ph+ cells from >=200 cells analyzed by FISH or MMR (<=0.1% BCR-ABL1 on the IS with at least 10,000 ABL1 transcripts assessed by central laboratory). Confirmed loss: 2 consecutive non-response assessments >=28 days apart. Progression: for CP: participants evolving from CP to AP, loss of CHR; loss of MCyR; in participants without CHR WBC >20*10^9/L on 2 occasions >=2 weeks apart after the first 4 weeks of treatment; for AP: confirmed BP, loss of previous hematologic response over a 2-week period, loss of CHR, no decrease from baseline levels (if considered clinically relevant) in percentage blasts in peripheral blood or bone marrow on all assessments over a 4-week period.
measure: Kaplan-Meier Estimate of Probability of Retaining Major Molecular Response (MMR) at Month 36
time frame: At Month 36
description: Kaplan-Meier analysis. Duration of MMR: from first date of MMR to confirmed loss of MMR/disease progression/on-treatment death or censoring, analyzed for responders only. MMR:<=0.1% BCR-ABL1 on the IS with at least 10,000 ABL1 transcripts assessed by central laboratory . Confirmed loss: 2 consecutive non-response assessments >=28 days apart with a <3-log (>0.1%) reduction in transcripts one of which corresponds to a <=2-log reduction (>=1%). Progression: for CP: participants evolving from CP to AP, loss of CHR; loss of MCyR; in participants without CHR WBC >20*10^9/L on 2 occasions >=2weeks apart after the first 4 weeks of treatment; for AP: confirmed BP, loss of previous hematologic response over a 2-week period, loss of CHR, no decrease from baseline levels (if considered clinically relevant) in percentage blasts in peripheral blood or bone marrow on all assessments over a 4-week period.
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs
time frame: First dose of study drug up to 28 days after last dose (up to maximum of 4 years)
description: An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAE: any event increasing in severity from baseline or any new event started during bosutinib therapy or within 28 days of the last dose of study drug. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly.
measure: Number of Participants With Grade 3 or 4 Treatment Emergent Adverse Events (TEAEs) Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
time frame: First dose of study drug up to 28 days after last dose (up to maximum of 4 years)
description: An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAE was any event increasing in severity from baseline or any new event that started during bosutinib therapy or within 28 days of the last dose of study drug. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Number of participants with Grade 3 or 4 TEAEs are reported.
measure: Number of Participants With Treatment Related Treatment Emergent Adverse Events (TEAEs)
time frame: First dose of study drug up to 28 days after last dose (up to maximum of 4 years)
description: An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAE was any event increasing in severity from baseline or any new event that started during bosutinib therapy or within 28 days of the last dose of study drug. Relatedness to drug was assessed by investigator.
measure: Number of Participants With Laboratory Abnormalities Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
time frame: First dose of study drug up to 28 days after last dose (up to maximum of 4 years)
description: Number of participants with any hematological, chemistry and coagulation abnormality of any grade were reported. Hematological: absolute neutrophil count (low), hemoglobin (low), lymphocytes (low), platelets (low) and leukocytes (low). Chemistry: alkaline phosphatase (high), alanine aminotransferase (high), amylase (high), aspartate aminotransferase (high), bilirubin (high), creatinine (high), lipase (high). Coagulation: activated partial prothrombin time (low), prothrombin time (low and high), partial prothrombin time (high).
arm group label: Bosutinib
arm group type: Experimental
intervention type: Drug
intervention name: Bosutinib
description: 100 mg and 500 mg tablets, once daily dosage up to 4 years duration
arm group label: Bosutinib
other name: BOSULIF
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: Austria
country: France
country: Germany
country: Italy
country: Norway
country: Spain
country: Sweden
country: United States
country: Belgium
country: Finland
country: Netherlands
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1871039&StudyName=Safety%20And%20Efficacy%20Study%20Of%20Bosutinib%20In%20Patients%20With%20Philadelphia%20Chromosome%20Positive%20Chronic%20Myeloid%20Leukemia%20Previously%20Treated%20With%20
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myelogenous, Chronic, BCR-ABL Positive
mesh term: Philadelphia Chromosome
sharing ipd: Yes
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
ipd url: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 