<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/NCT01667133</url>
  </required_header>
  <id_info>
    <org_study_id>AP24534-11-106</org_study_id>
    <nct_id>NCT01667133</nct_id>
  </id_info>
  <brief_title>A Study of Ponatinib in Japanese Participants With Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (ALL)</brief_title>
  <official_title>A Phase 1/2 Multi-center, Open-label Study of Ponatinib in Japanese Patients With Chronic Myeloid Leukemia (CML) Who Have Failed Dasatinib or Nilotinib or Ph+ Acute Lymphoblastic Leukemia (ALL) Who Have Failed Prior Tyrosine Kinase Inhibitors (TKIs)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ariad Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety and efficacy of ponatinib in Japanese&#xD;
      patients with chronic myeloid leukemia (CML) who have experienced failure of dasatinib or&#xD;
      nilotinib or with Ph+ acute lymphoblastic leukemia (ALL) following failure of prior tyrosine&#xD;
      kinase inhibitors (TKIs).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This multi-center, phase 1/2, open-label study will consist of two phases. The first will be&#xD;
      a dose escalation phase employing a modified 3+3 design with two dose cohorts (30mg and&#xD;
      45mg). After 6 patients complete the first cycle in a cohort, safety events will be evaluated&#xD;
      before opening the next dose cohort. Patients will continue on treatment as long as it is&#xD;
      tolerated and disease progression has not occurred. Phase 2 will occur at the recommended&#xD;
      dose determined in phase 1 in an additional 25 patients. Another 3 patients will be dosed at&#xD;
      15mg for collection of pharmacokinetic data. These patients may also escalate to the&#xD;
      recommended dose and be assessed for efficacy and safety as phase 2 patients.&#xD;
&#xD;
      Efficacy measures include molecular, cytogenetic, and hematologic response rates at various&#xD;
      time points; time to response; duration of response; and survival follow-up. Safety measures&#xD;
      include routine physical and laboratory evaluations, adverse event monitoring, and ECGs.&#xD;
      Other measures include mutation testing and molecular genetic assessment. Accrual is expected&#xD;
      to take approximately 12 months, and patients will be followed for survival for up to 60&#xD;
      months from the last dose of study drug; therefore, the estimated duration of the trial is 72&#xD;
      months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 31, 2012</start_date>
  <completion_date type="Actual">August 2, 2018</completion_date>
  <primary_completion_date type="Actual">August 2, 2018</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs) as a Measure of Safety Profile to Determine Recommended Dose of Ponatinib</measure>
    <time_frame>Cycle 1 (Cycle length= 28 days)</time_frame>
    <description>DLT was evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 and was defined as any of the following events: 1. Grade greater than or equal to (&gt;=) 3 non-hematologic, with the exception of medically controllable toxicities (example; nausea, vomiting, fatigue, electrolyte disturbances, hypersensitivity reactions) lasting &lt;=3 days, but excluding alopecia; 2. Missed doses: &gt;25% of planned ponatinib doses over 28 days due to AEs in the first cycle; 3. Febrile neutropenia (the occurrence of an ANC &lt;500/microliter concurrently with a temperature elevation of &gt;101 degree Fahrenheit), when neutropenia is not related to underlying acute leukemia, as defined hematologic toxicity: Dose-limiting hematologic toxicity is the occurrence of a Grade 4 cytopenia &gt;28 days, not related to underlying disease according to the investigator. Bone marrow examination must demonstrate &lt;5% cellularity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 2, CP-CML Participants: Percentage of Participants With Major Cytogenetic Response (MCyR)</measure>
    <time_frame>Baseline up to 60 months</time_frame>
    <description>MCyR was defined as percentage of participants who achieved a complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR) after the initiation of study treatment. Cytogenic response was the percentage of Philadelphia chromosome positive (Ph+) metaphases in bone marrow. CCyR: no Ph+ cells. PCyR: 1% to 35% Ph+ cells. Participants entering the study already in PCyR had to achieve a CCyR in order to be considered a success for the confirmed MCyR rate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 2, BP-CML and Ph+ALL: Percentage of Participants With Major Hematologic Response (MaHR)</measure>
    <time_frame>Baseline up to 60 months</time_frame>
    <description>MaHR was defined as percentage of participants with complete hematologic response (CHR) or no evidence of leukemia (NEL). MaHR response was confirmed by a peripheral blood complete blood count (CBC) and differential no earlier than 28 days after the response was observed. Response criteria for CHR was reported as white blood cells (WBC)&lt;=institutional upper limit of normal (ULN), absolute neutrophil count (ANC)&gt;=1000/mm^3, platelets&gt;=100,000/mm^3, no blasts or promyelocytes in peripheral blood, BM blasts &lt;=5%, &lt;5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood &lt;5%, no extramedullary involvement; Response criteria for NEL reported as WBC&lt;=institutional ULN, no blasts or promyelocytes in peripheral blood, BM blasts &lt;=5%, &lt;5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood &lt;5%, no extramedullary involvement, at least 1 of the following: (i) 20,000/mm^3&lt;=platelets&lt;100,000/mm^3; (ii) 500/mm^3&lt;=ANC&lt;1000/mm^3.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CP-CML Participants: Percentage of Participants With CHR</measure>
    <time_frame>Baseline up to 60 months</time_frame>
    <description>Hematologic response was defined as CHR for CP-CML participants. Participants who entered the trial in CHR and continued to meet the criteria for CHR on study were analyzed as responders. Response criteria for CHR was reported as WBC &lt;=institutional ULN, platelets &lt;450,000 per cubic millimeter (/mm^3), no blasts or promyelocytes in peripheral blood, &lt;5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood &lt;5%, no extramedullary involvement (including no hepatomegaly or splenomegaly).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CP-CML, AP-CML, BP-CML, and Ph+ALL Participants: Percentage of Participants With Confirmed MCyR</measure>
    <time_frame>Baseline up to 60 months</time_frame>
    <description>Confirmed MCyR was defined as 2 assessments of CCyR or PCyR at least 28 days apart. Participants entering the trial in PCyR must achieve two consecutive assessments of CCyR no fewer than 28 days apart in order to be considered as meeting the criteria for confirmed MCyR. Participants entering the trial in less than PCyR must achieve two consecutive assessments of PCyR or CCyR no fewer than 28 days apart in order to be considered as meeting the criteria for confirmed MCyR. CCyR: no Ph+ cells. PCyR: 1% to 35% Ph+ cells.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CP-CML, AP-CML, BP-CML, and Ph+ALL Participants: Percentage of Participants With Major Molecular Response (MMR)</measure>
    <time_frame>Baseline up to 60 months</time_frame>
    <description>MMR was defined as a ratio of reverse transcribed transcript of BCR-ABL to ABL &lt;=0.1% on the International scale (equivalent to a 3-log reduction in transcript). Participants were non-responders in any of the following situations: BCR-ABL or ABL levels not detectable at baseline, no valid baseline or post-baseline assessment, and baseline assessment for e1a2 variant only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CP-CML, AP-CML, BP-CML, and Ph+ALL Participants: Median Time to Response (TTR)</measure>
    <time_frame>From the first dose of study treatment until the criteria for response were first met (up to 60 months)</time_frame>
    <description>Time to response was defined as the interval from the first dose of study treatment until the criteria for response were first met, censored at the last assessment of response. Median time to response was estimated by Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CP-CML and Advanced Phase Participants: Median Duration of Response (DOR)</measure>
    <time_frame>From the first assessment at which criteria for response was met until the criteria for progression was first met (up to 60 months)</time_frame>
    <description>DOR: interval between first assessment at which criteria for response was met, until criteria for progression was met, censored at last date at which criteria for response was met. DOR was estimated using the Kaplan-Meier method. Progression criteria for CP was: death, development of AP/BP, or loss of CHR (in absence of cytogenic response), or loss of MCyR, or increasing WBC in participant without CHR (doubling of WBCs to &gt;20,000 on 2 occasions at least 4 weeks apart, after first week of therapy), as confirmed by development in complete blood cells (CBCs) at least 4 weeks apart; AP was: death, development of confirmed BP, loss of previous major/minor hematologic response over-2 week period, or no decrease from baseline levels in percentage blasts in peripheral blood/BM on all assessments over a 4-week period; and BP/Ph+ALL was: death/increasing blasts in peripheral blood or BM over a 4-week period. As planned, DOR is reported for all participants by entry mutation (T315I and Other).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CP-CML and Advanced Phase Participants: Median Progression-free Survival (PFS)</measure>
    <time_frame>From the first assessment at which criteria for response was met until the criteria for progression or death was met (up to 60 months)</time_frame>
    <description>PFS: interval from the first dose of study treatment until the criteria for progression or death were met, censored at the last response assessment. PFS was estimated using the Kaplan-Meier method. Progression criteria for CP was: death, development of AP/BP, or loss of CHR (in absence of cytogenic response), or loss of MCyR, or increasing WBC in participant without CHR (doubling of WBCs to &gt;20,000 on 2 occasions at least 4 weeks apart, after first week of therapy), as confirmed by development in CBCs at least 4 weeks apart; AP was: death, development of confirmed BP, loss of previous major/minor hematologic response over-2 week period, or no decrease from baseline levels in percentage blasts in peripheral blood/BM on all assessments over a 4-week period; BP/Ph+ALL was: death or increasing blasts in peripheral blood or BM over a 4-week period. As planned, PFS is reported for all participants by entry mutation (T315I and Other).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CP-CML and Advanced Phase Participants: Overall Survival (OS)</measure>
    <time_frame>From the first dose of study treatment until death (up to 60 months)</time_frame>
    <description>OS was defined as the interval from the first dose of study treatment until death, censored at the last date at which participant was known to be alive. Overall survival was estimated using the Kaplan-Meier method. As planned, OS is reported for all participants by entry mutation (T315I and Other).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax: Maximum Observed Plasma Concentration for Ponatinib</measure>
    <time_frame>Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax: Time to Reach the Cmax for Ponatinib</measure>
    <time_frame>Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC(0-24): Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose for Ponatinib</measure>
    <time_frame>Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T1/2: Terminal Phase Elimination Half-life for Ponatinib</measure>
    <time_frame>Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Chronic Myeloid Leukemia (CML)</condition>
  <condition>Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)</condition>
  <arm_group>
    <arm_group_label>Phase 1 dose escalation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phase 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2 expansion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phase 2</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ponatinib - Phase 1</intervention_name>
    <description>30 mg dose of ponatinib taken orally once daily for at least the first 6 patients. If no dose-limiting toxicities are observed, the next patients will receive 45 mg dose of ponatinib taken orally once daily. Once the recommended dose is confirmed, all patients may receive the recommended dose, at the investigators' discretion.</description>
    <arm_group_label>Phase 1 dose escalation</arm_group_label>
    <other_name>AP24534</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ponatinib - Phase 2</intervention_name>
    <description>Recommended dose of ponatinib as determined in the dose escalation phase. In addition, 3 patients will receive 15 mg dose once daily for 8 days for PK testing. These PK patients may be allowed to receive the recommended dose after PK testing is complete, at the investigators' discretion.</description>
    <arm_group_label>Phase 2 expansion</arm_group_label>
    <other_name>AP24534</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients must have CML in any phase (CP, AP, or BP of any phenotype) or Ph+ ALL, as&#xD;
             follows:&#xD;
&#xD;
               -  All patients must have screening bone marrow (BM) cytogenetics with conventional&#xD;
                  banding performed within 42 days prior to beginning treatment.&#xD;
&#xD;
               -  Examination of at least 20 metaphases is required in patients in CP. If less than&#xD;
                  20 metaphases are examined, the BM aspirate must be repeated.&#xD;
&#xD;
               -  Adequate BM aspirate with differential cell counts is required in patients with&#xD;
                  AP, BP, or Ph+ ALL. If an adequate aspirate is not obtained, the aspirate must be&#xD;
                  repeated.&#xD;
&#xD;
          2. Be previously treated with and resistant, or intolerant, as defined in the protocol,&#xD;
             to either dasatinib or nilotinib for CML or at least one TKI for Ph+ ALL, regardless&#xD;
             of whether dasatinib or nilotinib or the prior TKI were used to treat newly diagnosed&#xD;
             or resistant patients.&#xD;
&#xD;
          3. Must be ≥ 18 years old.&#xD;
&#xD;
          4. Provide written informed consent.&#xD;
&#xD;
          5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.&#xD;
&#xD;
          6. Minimum life expectancy of 3 months or more.&#xD;
&#xD;
          7. Adequate renal function defined as serum creatinine &lt; 1.5 × upper limit of normal&#xD;
             (ULN) for institution.&#xD;
&#xD;
          8. Adequate hepatic function defined as:&#xD;
&#xD;
               1. Total bilirubin &lt; 1.5 × ULN&#xD;
&#xD;
               2. Alanine aminotransferase (ALT [SGPT]) and aspartate aminotransferase (AST [SGOT])&#xD;
                  &lt; 2.5 × ULN for institution (&lt; 5 × ULN if liver involvement with leukemia)&#xD;
&#xD;
               3. Prothrombin time &lt; 1.5 × ULN&#xD;
&#xD;
          9. Normal pancreatic status defined as:&#xD;
&#xD;
               1. Lipase ≤ 1.5 × ULN for institution&#xD;
&#xD;
               2. Amylase ≤ 1.5 × ULN for institution&#xD;
&#xD;
         10. Normal QT interval corrected (Fridericia) (QTcF) interval on screening ECG evaluation,&#xD;
             defined as QTcF of ≤ 450 ms in males or ≤ 470 ms in females.&#xD;
&#xD;
         11. For females of childbearing potential, a negative pregnancy test must be documented&#xD;
             prior to enrolment.&#xD;
&#xD;
         12. Female and male patients who are of childbearing potential must agree to use an&#xD;
             effective form of contraception with their sexual partners throughout participation in&#xD;
             this study.&#xD;
&#xD;
         13. Ability to comply with study procedures, in the Investigator's opinion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients are not eligible for participation in the study if they meet any of the following&#xD;
        exclusion criteria:&#xD;
&#xD;
          1. Received TKI therapy within 7 days prior to receiving the first dose of ponatinib, or&#xD;
             have not recovered (&gt; grade 1 by National Cancer Institute Common Terminology Criteria&#xD;
             for Adverse Events, version 4.0 [NCI CTCAE v.4.0]) from adverse events (AEs) (except&#xD;
             alopecia) due to agents previously administered.&#xD;
&#xD;
          2. Received other therapies as follows:&#xD;
&#xD;
               1. For CP and AP patients, received interferon, cytarabine, or immunotherapy within&#xD;
                  14 days, or any other cytotoxic chemotherapy, radiotherapy, or investigational&#xD;
                  therapy within 28 days prior to receiving the first dose of ponatinib.&#xD;
&#xD;
               2. For BP patients, received chemotherapy within 7 days prior to the first dose of&#xD;
                  ponatinib. Otherwise, 2a applies.&#xD;
&#xD;
               3. For Ph+ ALL patients, received corticosteroids within 24 hours before the first&#xD;
                  dose of ponatinib and other chemotherapy within 7 days prior to the first dose of&#xD;
                  ponatinib. Otherwise, 2a applies.&#xD;
&#xD;
               4. All patients are excluded if they have not recovered (&gt; grade 1 by NCI CTCAE&#xD;
                  v.4.0) from AEs (except alopecia) due to agents previously administered.&#xD;
&#xD;
          3. Underwent autologous or allogeneic stem cell transplant &lt; 60 days prior to receiving&#xD;
             the first dose of ponatinib; any evidence of ongoing graft versus-host disease (GVHD)&#xD;
             or GVHD requiring immunosuppressive therapy.&#xD;
&#xD;
          4. Take medications that are known to be associated with Torsades de Pointes.&#xD;
&#xD;
          5. Require concurrent treatment with immunosuppressive agents, other than corticosteroids&#xD;
             prescribed for a short course of therapy.&#xD;
&#xD;
          6. Have previously been treated with ponatinib.&#xD;
&#xD;
          7. Patients with CP-CML are excluded if they are in CCyR.&#xD;
&#xD;
          8. Patients with CP-CML are excluded if a baseline BM aspirate adequate for conventional&#xD;
             cytogenetic analysis with 20 metaphases examined is not available.&#xD;
&#xD;
          9. Patients with AP-CML, BP-CML, or Ph+ ALL are excluded if they are in MaHR.&#xD;
&#xD;
         10. Patients with AP-CML, BP-CML, or Ph+ ALL are excluded if a baseline BM aspirate&#xD;
             adequate for cell count and differential report is not available. Patients with a&#xD;
             fibrotic marrow or dry tap that does not yield adequate cell counts for diagnosis are&#xD;
             not evaluable for classification, and endpoints are not eligible.&#xD;
&#xD;
         11. Have active central nervous system (CNS) disease as evidenced by cytology or&#xD;
             pathology. In the absence of clinical CNS disease, lumbar puncture is not required.&#xD;
             History itself of CNS involvement is not exclusionary if CNS has been cleared with a&#xD;
             documented negative lumbar puncture.&#xD;
&#xD;
         12. Have significant or active cardiovascular disease, specifically including, but not&#xD;
             restricted to:&#xD;
&#xD;
               1. Myocardial infarction within 3 months prior to first dose of ponatinib&#xD;
&#xD;
               2. History of clinically significant atrial arrhythmia or any ventricular arrhythmia&#xD;
&#xD;
               3. Unstable angina within 3 months prior to first dose of ponatinib&#xD;
&#xD;
               4. Congestive heart failure within 3 months prior to first dose of ponatinib&#xD;
&#xD;
         13. Have a significant bleeding disorder unrelated to CML or Ph+ ALL.&#xD;
&#xD;
         14. Have a history of pancreatitis or alcohol abuse.&#xD;
&#xD;
         15. Have uncontrolled hypertriglyceridemia (triglycerides &gt; 450 mg/dL).&#xD;
&#xD;
         16. Have malabsorption syndrome or other gastrointestinal illness that could affect&#xD;
             absorption of orally administered ponatinib.&#xD;
&#xD;
         17. Have been diagnosed with another primary malignancy within the past 3 years (except&#xD;
             for non-melanoma skin cancer or cervical cancer in situ, or controlled prostate&#xD;
             cancer, which are allowed within 3 years).&#xD;
&#xD;
         18. Are pregnant or lactating. Women of childbearing potential must agree to an effective&#xD;
             contraception from the time of signing the informed consent through the Follow-up&#xD;
             Visit, approximately 30 days after last dose of ponatinib.&#xD;
&#xD;
         19. Underwent major surgery (with the exception of minor surgical procedures, such as&#xD;
             catheter placement or BM biopsy) within 14 days prior to first dose of ponatinib.&#xD;
&#xD;
         20. Have ongoing or active infection (including known history of human immunodeficiency&#xD;
             virus [HIV], hepatitis B virus [HBV], or hepatitis C virus [HCV]). Testing for these&#xD;
             viruses is not required in the absence of history.&#xD;
&#xD;
         21. Suffer from any condition or illness that, in the opinion of the Investigator or the&#xD;
             Medical Monitor, would compromise patients safety or interfere with the evaluation of&#xD;
             the safety of the study drug.&#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>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aichi Cancer Center Hospital</name>
      <address>
        <city>Nagoya-shi</city>
        <state>Aichi</state>
        <zip>464-8681</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akita University Hospital</name>
      <address>
        <city>Akita-shi</city>
        <state>Akita</state>
        <zip>010-8543</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hiroshima Red Cross Hospital &amp; Atomic-bomb Survivors Hospital</name>
      <address>
        <city>Hiroshima-shi</city>
        <state>Hiroshima</state>
        <zip>730-8619</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyushu University Hospital</name>
      <address>
        <city>Hukuoka-shi</city>
        <state>Hukuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kinki University Hospital, Faculty of Medicine</name>
      <address>
        <city>Osakasayama-shi</city>
        <state>Osaka</state>
        <zip>589-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cancer Institute Hospital Japanese Foundation for Cancer Research</name>
      <address>
        <city>Koto</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Tokyo, The Institute of Medical Science</name>
      <address>
        <city>Minato-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keio University Hospital</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka City University Hospital</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital</name>
      <address>
        <city>Chuo-ku, Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical University Hospital</name>
      <address>
        <city>Shinjuku-ku, Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <results_first_submitted>March 1, 2021</results_first_submitted>
  <results_first_submitted_qc>March 9, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">June 13, 2022</results_first_posted>
  <last_update_submitted>March 9, 2022</last_update_submitted>
  <last_update_submitted_qc>March 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Leukemia</keyword>
  <keyword>Leukemia, Myeloid</keyword>
  <keyword>Leukemia, Myelogenous, Chronic, BCR-ABL Positive</keyword>
  <keyword>Neoplasms by Histologic Type</keyword>
  <keyword>Neoplasms</keyword>
  <keyword>Lymphoproliferative Disorders</keyword>
  <keyword>Lymphatic Diseases</keyword>
  <keyword>Immunoproliferative Disorders</keyword>
  <keyword>Immune System Diseases</keyword>
  <keyword>Myeloproliferative Disorders</keyword>
  <keyword>Bone Marrow Diseases</keyword>
  <keyword>Hematologic Diseases</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>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
    <mesh_term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive</mesh_term>
    <mesh_term>Philadelphia Chromosome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ponatinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_access_criteria>IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/takeda/</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>November 21, 2013</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT01667133/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>March 4, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT01667133/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 9 investigative sites in Japan from 31 August 2012 to 02 August 2018.</recruitment_details>
      <pre_assignment_details>Participants with CP-CML, AP-CML, or BP-CML, or with Ph+ALL were enrolled in Phase 1 (dose-escalation) to receive 30 or 45 mg of ponatinib and recommended phase 2 dose in Phase 2 (expansion). As there was no participant enrolled in Phase 1: BP-CML Ponatinib 30 milligram (mg) arm, therefore the arm is not reported in the result summary. Participants in Phase 1 with CP-CML or AP-CML, BP-CML or Ph+ ALL and who had T315I mutation and other mutations were analyzed as subgroups in the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Ponatinib 30 mg: Phase 1 CP-CML</title>
          <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with chronic phase (CP)-chronic myeloid leukemia (CML) resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
        </group>
        <group group_id="P2">
          <title>Ponatinib 30 mg: Phase 1 AP-CML</title>
          <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with accelerated phase (AP)- CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
        </group>
        <group group_id="P3">
          <title>Ponatinib 30 mg: Phase 1 Ph+ ALL</title>
          <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Philadelphia chromosome plus acute lymphoblastic leukemia (Ph+ ALL) resistant or intolerant to prior tyrosine kinase inhibitor (TKIs) in Dose-escalation Phase 1.</description>
        </group>
        <group group_id="P4">
          <title>Ponatinib 45 mg: Phase 1 CP-CML</title>
          <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
        </group>
        <group group_id="P5">
          <title>Ponatinib 45 mg: Phase 1 AP-CML</title>
          <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
        </group>
        <group group_id="P6">
          <title>Ponatinib 45 mg: Phase 1 BP-CML</title>
          <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
        </group>
        <group group_id="P7">
          <title>Ponatinib 45 mg: Phase 1 Ph+ ALL</title>
          <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.</description>
        </group>
        <group group_id="P8">
          <title>Ponatinib 15 mg: Phase 2 CP- CML</title>
          <description>Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).</description>
        </group>
        <group group_id="P9">
          <title>Ponatinib 15 mg: Phase 2 Ph+ ALL</title>
          <description>Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with Ph+ ALL resistant or intolerant to prior TKIs in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months).</description>
        </group>
        <group group_id="P10">
          <title>Ponatinib 45 mg: Phase 2 CP-CML</title>
          <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.</description>
        </group>
        <group group_id="P11">
          <title>Ponatinib 45 mg: Phase 2 BP-CML</title>
          <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.</description>
        </group>
        <group group_id="P12">
          <title>Ponatinib 45 mg: Phase 2 PH+ ALL</title>
          <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with PH+ ALL resistant or intolerant to prior TKI in Expansion Phase 2.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Phase 1: Dose-escalation</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</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 group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</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 group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive Disease</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="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="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Phase 2: Dose-expansion</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="11"/>
                <participants group_id="P11" count="3"/>
                <participants group_id="P12" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="5"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="6"/>
                <participants group_id="P11" count="3"/>
                <participants group_id="P12" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive Disease</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="3"/>
                <participants group_id="P12" count="5"/>
              </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="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Treated population included all participants who had received at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Ponatinib 30 mg: Phase 1 CP-CML</title>
          <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
        </group>
        <group group_id="B2">
          <title>Ponatinib 30 mg: Phase 1 AP-CML</title>
          <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
        </group>
        <group group_id="B3">
          <title>Ponatinib 30 mg: Phase 1 Ph+ ALL</title>
          <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.</description>
        </group>
        <group group_id="B4">
          <title>Ponatinib 45 mg: Phase 1 CP-CML</title>
          <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
        </group>
        <group group_id="B5">
          <title>Ponatinib 45 mg: Phase 1 AP-CML</title>
          <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
        </group>
        <group group_id="B6">
          <title>Ponatinib 45 mg: Phase 1 BP-CML</title>
          <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
        </group>
        <group group_id="B7">
          <title>Ponatinib 45 mg: Phase 1 Ph+ ALL</title>
          <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.</description>
        </group>
        <group group_id="B8">
          <title>Ponatinib 15 mg: Phase 2 CP-CML</title>
          <description>Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment Cycle for up to unacceptable drug reaction or disease progression (up to 60 months).</description>
        </group>
        <group group_id="B9">
          <title>Ponatinib 15 mg: Phase 2 Ph+ ALL</title>
          <description>Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with Ph+ ALL resistant or intolerant to prior TKIs in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment Cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months).</description>
        </group>
        <group group_id="B10">
          <title>Ponatinib 45 mg: Phase 2 CP-CML</title>
          <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.</description>
        </group>
        <group group_id="B11">
          <title>Ponatinib 45 mg: Phase 2 BP-CML</title>
          <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.</description>
        </group>
        <group group_id="B12">
          <title>Ponatinib 45 mg: Phase 2 PH+ ALL</title>
          <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with PH+ ALL resistant or intolerant to prior TKI in Expansion Phase 2.</description>
        </group>
        <group group_id="B13">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
            <count group_id="B2" value="1"/>
            <count group_id="B3" value="4"/>
            <count group_id="B4" value="3"/>
            <count group_id="B5" value="1"/>
            <count group_id="B6" value="1"/>
            <count group_id="B7" value="1"/>
            <count group_id="B8" value="2"/>
            <count group_id="B9" value="1"/>
            <count group_id="B10" value="11"/>
            <count group_id="B11" value="3"/>
            <count group_id="B12" value="6"/>
            <count group_id="B13" value="35"/>
          </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="61.0"/>
                    <measurement group_id="B2" value="62.0"/>
                    <measurement group_id="B3" value="56.5" spread="11.73"/>
                    <measurement group_id="B4" value="60.7" spread="12.86"/>
                    <measurement group_id="B5" value="57.0"/>
                    <measurement group_id="B6" value="58.0"/>
                    <measurement group_id="B7" value="30.0"/>
                    <measurement group_id="B8" value="61.5" spread="14.85"/>
                    <measurement group_id="B9" value="76.0"/>
                    <measurement group_id="B10" value="59.1" spread="13.78"/>
                    <measurement group_id="B11" value="67.7" spread="4.04"/>
                    <measurement group_id="B12" value="58.3" spread="13.78"/>
                    <measurement group_id="B13" value="59.4" spread="12.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="6"/>
                    <measurement group_id="B11" value="1"/>
                    <measurement group_id="B12" value="4"/>
                    <measurement group_id="B13" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="5"/>
                    <measurement group_id="B11" value="2"/>
                    <measurement group_id="B12" value="2"/>
                    <measurement group_id="B13" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="11"/>
                    <measurement group_id="B11" value="3"/>
                    <measurement group_id="B12" value="6"/>
                    <measurement group_id="B13" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="11"/>
                    <measurement group_id="B11" value="3"/>
                    <measurement group_id="B12" value="6"/>
                    <measurement group_id="B13" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kilogram (kg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.0"/>
                    <measurement group_id="B2" value="57.0"/>
                    <measurement group_id="B3" value="45.8" spread="3.93"/>
                    <measurement group_id="B4" value="74.1" spread="6.49"/>
                    <measurement group_id="B5" value="55.8"/>
                    <measurement group_id="B6" value="60.0"/>
                    <measurement group_id="B7" value="54.6"/>
                    <measurement group_id="B8" value="60.0" spread="8.49"/>
                    <measurement group_id="B9" value="60.5"/>
                    <measurement group_id="B10" value="59.0" spread="9.93"/>
                    <measurement group_id="B11" value="54.0" spread="10.99"/>
                    <measurement group_id="B12" value="53.7" spread="11.84"/>
                    <measurement group_id="B13" value="57.5" spread="10.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>centimeter (cm)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="163.6"/>
                    <measurement group_id="B2" value="155.9"/>
                    <measurement group_id="B3" value="165.1" spread="8.89"/>
                    <measurement group_id="B4" value="172.4" spread="6.61"/>
                    <measurement group_id="B5" value="170.5"/>
                    <measurement group_id="B6" value="156.4"/>
                    <measurement group_id="B7" value="170.7"/>
                    <measurement group_id="B8" value="169.5" spread="2.83"/>
                    <measurement group_id="B9" value="166.0"/>
                    <measurement group_id="B10" value="159.5" spread="10.15"/>
                    <measurement group_id="B11" value="162.4" spread="6.92"/>
                    <measurement group_id="B12" value="158.0" spread="8.95"/>
                    <measurement group_id="B13" value="162.5" spread="8.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Eastern Cooperative Oncology Group (ECOG) Performance Status</title>
          <description>ECOG performance status used by doctors/researchers to assess how participant's disease is progressing, assess how disease affects daily living activities of participant and determine appropriate treatment/prognosis on 5-point scale. 0=Actively able to do activities; 1=Restricted in physical activity, able to do light/sedentary work; 2=Ambulatory (&gt;50% of waking hours), capable of self-care, unable to do any work activities; 3=Capable of limited self-care, confined to bed &gt;50% of waking hours; 4=Completely disabled, cannot do any self-care, totally confined to bed; 5=dead.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>0 = Fully Active</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="11"/>
                    <measurement group_id="B11" value="1"/>
                    <measurement group_id="B12" value="6"/>
                    <measurement group_id="B13" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 = Restricted in Physical Activity; Ambulatory</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="2"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Participants with Initial Diagnosis of Leukemia</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>CP-CML</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="11"/>
                    <measurement group_id="B11" value="1"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP-CML</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="1"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BP-CML</title>
              <category_list>
                <category>
                  <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="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="1"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ph+ ALL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="6"/>
                    <measurement group_id="B13" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time Since Diagnosis to Date of First Dose</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.29" lower_limit="10.29" upper_limit="10.29"/>
                    <measurement group_id="B2" value="21.65" lower_limit="21.65" upper_limit="21.65"/>
                    <measurement group_id="B3" value="1.51" lower_limit="1.28" upper_limit="9.64"/>
                    <measurement group_id="B4" value="3.47" lower_limit="0.46" upper_limit="20.04"/>
                    <measurement group_id="B5" value="10.87" lower_limit="10.87" upper_limit="10.87"/>
                    <measurement group_id="B6" value="0.53" lower_limit="0.53" upper_limit="0.53"/>
                    <measurement group_id="B7" value="3.00" lower_limit="3.00" upper_limit="3.00"/>
                    <measurement group_id="B8" value="12.98" lower_limit="0.36" upper_limit="25.60"/>
                    <measurement group_id="B9" value="0.73" lower_limit="0.73" upper_limit="0.73"/>
                    <measurement group_id="B10" value="3.76" lower_limit="0.96" upper_limit="17.11"/>
                    <measurement group_id="B11" value="1.69" lower_limit="0.25" upper_limit="6.05"/>
                    <measurement group_id="B12" value="0.91" lower_limit="0.24" upper_limit="2.11"/>
                    <measurement group_id="B13" value="2.11" lower_limit="0.24" upper_limit="25.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Participants with Extramedullary Involvement</title>
          <description>Participants with extramedullary disease sites were assessed. Extramedullary disease occurs when myeloma cells form tumors outside the bone marrow in the soft tissues or organs of the body.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Hepatomegaly</title>
              <category_list>
                <category>
                  <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="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="1"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Splenomegaly</title>
              <category_list>
                <category>
                  <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="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No extramedullary involvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="11"/>
                    <measurement group_id="B11" value="2"/>
                    <measurement group_id="B12" value="6"/>
                    <measurement group_id="B13" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Participants with BCR-ABL Ratio</title>
          <description>Breakpoint cluster region-Abelson complex (BCR-ABL1) is an abnormal gene found in CML and acute lymphoblastic leukemia (ALL). The chromosomal defect in the Philadelphia chromosome is a translocation, in which parts of two chromosomes, 9 and 22, swap places. The result is that a fusion gene is created by juxtapositioning the Abl1 gene on chromosome 9 to a part of the BCR gene on chromosome 22. Depending upon the breakpoints on the BCR gene, there are several forms of fusion proteins. BCR-ABL ratio is assessed in % international scale (IS).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Greater than (&gt;)0.1 - less than or equal to (&lt;=)1%</title>
              <category_list>
                <category>
                  <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="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="1"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;1 to &lt;=10 percent (%)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="3"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;10%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="7"/>
                    <measurement group_id="B11" value="2"/>
                    <measurement group_id="B12" value="2"/>
                    <measurement group_id="B13" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>e1a2 variant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="4"/>
                    <measurement group_id="B13" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs) as a Measure of Safety Profile to Determine Recommended Dose of Ponatinib</title>
        <description>DLT was evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 and was defined as any of the following events: 1. Grade greater than or equal to (&gt;=) 3 non-hematologic, with the exception of medically controllable toxicities (example; nausea, vomiting, fatigue, electrolyte disturbances, hypersensitivity reactions) lasting &lt;=3 days, but excluding alopecia; 2. Missed doses: &gt;25% of planned ponatinib doses over 28 days due to AEs in the first cycle; 3. Febrile neutropenia (the occurrence of an ANC &lt;500/microliter concurrently with a temperature elevation of &gt;101 degree Fahrenheit), when neutropenia is not related to underlying acute leukemia, as defined hematologic toxicity: Dose-limiting hematologic toxicity is the occurrence of a Grade 4 cytopenia &gt;28 days, not related to underlying disease according to the investigator. Bone marrow examination must demonstrate &lt;5% cellularity.</description>
        <time_frame>Cycle 1 (Cycle length= 28 days)</time_frame>
        <population>DLT evaluable population (Phase 1 only) included all participants who had completed at least 75% of their planned doses during Cycle 1, unless missed doses were due to adverse events (AEs).</population>
        <group_list>
          <group group_id="O1">
            <title>Ponatinib 30 mg: Phase 1 CP-CML</title>
            <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O2">
            <title>Ponatinib 30 mg: Phase 1 AP-CML</title>
            <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O3">
            <title>Ponatinib 30 mg: Phase 1 Ph+ ALL</title>
            <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O4">
            <title>Ponatinib 45 mg: Phase 1 CP-CML</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O5">
            <title>Ponatinib 45 mg: Phase 1 AP CML</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O6">
            <title>Ponatinib 45 mg: Phase 1 BP-CML</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O7">
            <title>Ponatinib 45 mg: Phase 1 Ph+ ALL</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs) as a Measure of Safety Profile to Determine Recommended Dose of Ponatinib</title>
          <description>DLT was evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 and was defined as any of the following events: 1. Grade greater than or equal to (&gt;=) 3 non-hematologic, with the exception of medically controllable toxicities (example; nausea, vomiting, fatigue, electrolyte disturbances, hypersensitivity reactions) lasting &lt;=3 days, but excluding alopecia; 2. Missed doses: &gt;25% of planned ponatinib doses over 28 days due to AEs in the first cycle; 3. Febrile neutropenia (the occurrence of an ANC &lt;500/microliter concurrently with a temperature elevation of &gt;101 degree Fahrenheit), when neutropenia is not related to underlying acute leukemia, as defined hematologic toxicity: Dose-limiting hematologic toxicity is the occurrence of a Grade 4 cytopenia &gt;28 days, not related to underlying disease according to the investigator. Bone marrow examination must demonstrate &lt;5% cellularity.</description>
          <population>DLT evaluable population (Phase 1 only) included all participants who had completed at least 75% of their planned doses during Cycle 1, unless missed doses were due to adverse events (AEs).</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="1"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="1"/>
                <count group_id="O7" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Phase 2, CP-CML Participants: Percentage of Participants With Major Cytogenetic Response (MCyR)</title>
        <description>MCyR was defined as percentage of participants who achieved a complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR) after the initiation of study treatment. Cytogenic response was the percentage of Philadelphia chromosome positive (Ph+) metaphases in bone marrow. CCyR: no Ph+ cells. PCyR: 1% to 35% Ph+ cells. Participants entering the study already in PCyR had to achieve a CCyR in order to be considered a success for the confirmed MCyR rate.</description>
        <time_frame>Baseline up to 60 months</time_frame>
        <population>Treated population included all participants who had received at least 1 dose of study drug. This outcome measure was planned to be assessed only in CP-CML participants of Phase 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ponatinib 15 mg: Phase 2 CP-CML</title>
            <description>Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment Cycle for up to unacceptable drug reaction or disease progression (up to 60 months).</description>
          </group>
          <group group_id="O2">
            <title>Ponatinib 45 mg: Phase 2 CP-CML</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 2, CP-CML Participants: Percentage of Participants With Major Cytogenetic Response (MCyR)</title>
          <description>MCyR was defined as percentage of participants who achieved a complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR) after the initiation of study treatment. Cytogenic response was the percentage of Philadelphia chromosome positive (Ph+) metaphases in bone marrow. CCyR: no Ph+ cells. PCyR: 1% to 35% Ph+ cells. Participants entering the study already in PCyR had to achieve a CCyR in order to be considered a success for the confirmed MCyR rate.</description>
          <population>Treated population included all participants who had received at least 1 dose of study drug. This outcome measure was planned to be assessed only in CP-CML participants of Phase 2.</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="2"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50" lower_limit="1.3" upper_limit="98.7"/>
                    <measurement group_id="O2" value="63.6" lower_limit="30.8" upper_limit="89.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Phase 2, BP-CML and Ph+ALL: Percentage of Participants With Major Hematologic Response (MaHR)</title>
        <description>MaHR was defined as percentage of participants with complete hematologic response (CHR) or no evidence of leukemia (NEL). MaHR response was confirmed by a peripheral blood complete blood count (CBC) and differential no earlier than 28 days after the response was observed. Response criteria for CHR was reported as white blood cells (WBC)&lt;=institutional upper limit of normal (ULN), absolute neutrophil count (ANC)&gt;=1000/mm^3, platelets&gt;=100,000/mm^3, no blasts or promyelocytes in peripheral blood, BM blasts &lt;=5%, &lt;5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood &lt;5%, no extramedullary involvement; Response criteria for NEL reported as WBC&lt;=institutional ULN, no blasts or promyelocytes in peripheral blood, BM blasts &lt;=5%, &lt;5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood &lt;5%, no extramedullary involvement, at least 1 of the following: (i) 20,000/mm^3&lt;=platelets&lt;100,000/mm^3; (ii) 500/mm^3&lt;=ANC&lt;1000/mm^3.</description>
        <time_frame>Baseline up to 60 months</time_frame>
        <population>Treated population included all participants who had received at least 1 dose of study drug. This outcome measure was planned to be assessed only in BP-CML and Ph+ALL participants of Phase 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ponatinib 15 mg: Phase 2 Ph+ ALL</title>
            <description>Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with Ph+ ALL resistant or intolerant to prior TKIs in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment Cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months).</description>
          </group>
          <group group_id="O2">
            <title>Ponatinib 45 mg: Phase 2 BP-CML</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.</description>
          </group>
          <group group_id="O3">
            <title>Ponatinib 45 mg: Phase 2 PH+ ALL</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with PH+ ALL resistant or intolerant to prior TKI in Expansion Phase 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 2, BP-CML and Ph+ALL: Percentage of Participants With Major Hematologic Response (MaHR)</title>
          <description>MaHR was defined as percentage of participants with complete hematologic response (CHR) or no evidence of leukemia (NEL). MaHR response was confirmed by a peripheral blood complete blood count (CBC) and differential no earlier than 28 days after the response was observed. Response criteria for CHR was reported as white blood cells (WBC)&lt;=institutional upper limit of normal (ULN), absolute neutrophil count (ANC)&gt;=1000/mm^3, platelets&gt;=100,000/mm^3, no blasts or promyelocytes in peripheral blood, BM blasts &lt;=5%, &lt;5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood &lt;5%, no extramedullary involvement; Response criteria for NEL reported as WBC&lt;=institutional ULN, no blasts or promyelocytes in peripheral blood, BM blasts &lt;=5%, &lt;5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood &lt;5%, no extramedullary involvement, at least 1 of the following: (i) 20,000/mm^3&lt;=platelets&lt;100,000/mm^3; (ii) 500/mm^3&lt;=ANC&lt;1000/mm^3.</description>
          <population>Treated population included all participants who had received at least 1 dose of study drug. This outcome measure was planned to be assessed only in BP-CML and Ph+ALL participants of Phase 2.</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="1"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="97.5"/>
                    <measurement group_id="O2" value="33.3" lower_limit="0.8" upper_limit="90.6"/>
                    <measurement group_id="O3" value="83.3" lower_limit="35.9" upper_limit="99.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CP-CML Participants: Percentage of Participants With CHR</title>
        <description>Hematologic response was defined as CHR for CP-CML participants. Participants who entered the trial in CHR and continued to meet the criteria for CHR on study were analyzed as responders. Response criteria for CHR was reported as WBC &lt;=institutional ULN, platelets &lt;450,000 per cubic millimeter (/mm^3), no blasts or promyelocytes in peripheral blood, &lt;5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood &lt;5%, no extramedullary involvement (including no hepatomegaly or splenomegaly).</description>
        <time_frame>Baseline up to 60 months</time_frame>
        <population>Treated population included all participants who had received at least 1 dose of study drug. This outcome measure was planned to be assessed only in CP-CML Participants of Phase 1 and 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ponatinib 30 mg: Phase 1 CP-CML</title>
            <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O2">
            <title>Ponatinib 45 mg: Phase 1 CP-CML</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O3">
            <title>Ponatinib 15 mg: Phase 2 CP-CML</title>
            <description>Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment Cycle for up to unacceptable drug reaction or disease progression (up to 60 months).</description>
          </group>
          <group group_id="O4">
            <title>Ponatinib 45 mg: Phase 2 CP-CML</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.</description>
          </group>
        </group_list>
        <measure>
          <title>CP-CML Participants: Percentage of Participants With CHR</title>
          <description>Hematologic response was defined as CHR for CP-CML participants. Participants who entered the trial in CHR and continued to meet the criteria for CHR on study were analyzed as responders. Response criteria for CHR was reported as WBC &lt;=institutional ULN, platelets &lt;450,000 per cubic millimeter (/mm^3), no blasts or promyelocytes in peripheral blood, &lt;5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood &lt;5%, no extramedullary involvement (including no hepatomegaly or splenomegaly).</description>
          <population>Treated population included all participants who had received at least 1 dose of study drug. This outcome measure was planned to be assessed only in CP-CML Participants of Phase 1 and 2.</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="1"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="2.5" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="29.2" upper_limit="100"/>
                    <measurement group_id="O3" value="100" lower_limit="15.8" upper_limit="100"/>
                    <measurement group_id="O4" value="90.9" lower_limit="58.7" upper_limit="99.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CP-CML, AP-CML, BP-CML, and Ph+ALL Participants: Percentage of Participants With Confirmed MCyR</title>
        <description>Confirmed MCyR was defined as 2 assessments of CCyR or PCyR at least 28 days apart. Participants entering the trial in PCyR must achieve two consecutive assessments of CCyR no fewer than 28 days apart in order to be considered as meeting the criteria for confirmed MCyR. Participants entering the trial in less than PCyR must achieve two consecutive assessments of PCyR or CCyR no fewer than 28 days apart in order to be considered as meeting the criteria for confirmed MCyR. CCyR: no Ph+ cells. PCyR: 1% to 35% Ph+ cells.</description>
        <time_frame>Baseline up to 60 months</time_frame>
        <population>Treated population included all participants who had received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Ponatinib 30 mg: Phase 1 CP-CML</title>
            <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O2">
            <title>Ponatinib 30 mg: Phase 1 AP-CML</title>
            <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O3">
            <title>Ponatinib 30 mg: Phase 1 Ph+ ALL</title>
            <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O4">
            <title>Ponatinib 45 mg: Phase 1 CP-CML</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O5">
            <title>Ponatinib 45 mg: Phase 1 AP-CML</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O6">
            <title>Ponatinib 45 mg: Phase 1 BP-CML</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O7">
            <title>Ponatinib 45 mg: Phase 1 Ph+ ALL</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 in participant with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O8">
            <title>Ponatinib 15 mg: Phase 2 CP-CML</title>
            <description>Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).</description>
          </group>
          <group group_id="O9">
            <title>Ponatinib 15 mg: Phase 2 Ph+ ALL</title>
            <description>Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with Ph+ ALL resistant or intolerant to prior TKIs in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months).</description>
          </group>
          <group group_id="O10">
            <title>Ponatinib 45 mg: Phase 2 CP-CML</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.</description>
          </group>
          <group group_id="O11">
            <title>Ponatinib 45 mg: Phase 2 BP-CML</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 6 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.</description>
          </group>
          <group group_id="O12">
            <title>Ponatinib 45 mg: Phase 2 PH+ ALL</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with PH+ ALL resistant or intolerant to prior TKI in Expansion Phase 2.</description>
          </group>
        </group_list>
        <measure>
          <title>CP-CML, AP-CML, BP-CML, and Ph+ALL Participants: Percentage of Participants With Confirmed MCyR</title>
          <description>Confirmed MCyR was defined as 2 assessments of CCyR or PCyR at least 28 days apart. Participants entering the trial in PCyR must achieve two consecutive assessments of CCyR no fewer than 28 days apart in order to be considered as meeting the criteria for confirmed MCyR. Participants entering the trial in less than PCyR must achieve two consecutive assessments of PCyR or CCyR no fewer than 28 days apart in order to be considered as meeting the criteria for confirmed MCyR. CCyR: no Ph+ cells. PCyR: 1% to 35% Ph+ cells.</description>
          <population>Treated population included all participants who had received at least 1 dose of study drug.</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="1"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="1"/>
                <count group_id="O7" value="1"/>
                <count group_id="O8" value="2"/>
                <count group_id="O9" value="1"/>
                <count group_id="O10" value="11"/>
                <count group_id="O11" value="3"/>
                <count group_id="O12" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="2.5" upper_limit="100"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="97.5"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="60.2"/>
                    <measurement group_id="O4" value="100" lower_limit="29.2" upper_limit="100"/>
                    <measurement group_id="O5" value="100" lower_limit="2.5" upper_limit="100"/>
                    <measurement group_id="O6" value="100" lower_limit="2.5" upper_limit="100"/>
                    <measurement group_id="O7" value="100" lower_limit="2.5" upper_limit="100"/>
                    <measurement group_id="O8" value="0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O9" value="0" lower_limit="0.0" upper_limit="97.5"/>
                    <measurement group_id="O10" value="63.6" lower_limit="30.8" upper_limit="89.1"/>
                    <measurement group_id="O11" value="33.3" lower_limit="0.8" upper_limit="90.6"/>
                    <measurement group_id="O12" value="16.7" lower_limit="0.4" upper_limit="64.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CP-CML, AP-CML, BP-CML, and Ph+ALL Participants: Percentage of Participants With Major Molecular Response (MMR)</title>
        <description>MMR was defined as a ratio of reverse transcribed transcript of BCR-ABL to ABL &lt;=0.1% on the International scale (equivalent to a 3-log reduction in transcript). Participants were non-responders in any of the following situations: BCR-ABL or ABL levels not detectable at baseline, no valid baseline or post-baseline assessment, and baseline assessment for e1a2 variant only.</description>
        <time_frame>Baseline up to 60 months</time_frame>
        <population>Treated population included all participants who had received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Ponatinib 30 mg: Phase 1 CP-CML</title>
            <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O2">
            <title>Ponatinib 30 mg: Phase 1 AP-CML</title>
            <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O3">
            <title>Ponatinib 30 mg: Phase 1 Ph+ ALL</title>
            <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O4">
            <title>Ponatinib 45 mg: Phase 1 CP-CML</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O5">
            <title>Ponatinib 45 mg: Phase 1 AP-CML</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O6">
            <title>Ponatinib 45 mg: Phase 1 BP-CML</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O7">
            <title>Ponatinib 45 mg: Phase 1 Ph+ ALL</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 in participant with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O8">
            <title>Ponatinib 15 mg: Phase 2 CP-CML</title>
            <description>Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).</description>
          </group>
          <group group_id="O9">
            <title>Ponatinib 15 mg: Phase 2 Ph+ ALL</title>
            <description>Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with Ph+ ALL resistant or intolerant to prior TKIs in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months).</description>
          </group>
          <group group_id="O10">
            <title>Ponatinib 45 mg: Phase 2 CP-CML</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.</description>
          </group>
          <group group_id="O11">
            <title>Ponatinib 45 mg: Phase 2 BP-CML</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.</description>
          </group>
          <group group_id="O12">
            <title>Ponatinib 45 mg: Phase 2 PH+ ALL</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with PH+ ALL resistant or intolerant to prior TKI in Expansion Phase 2.</description>
          </group>
        </group_list>
        <measure>
          <title>CP-CML, AP-CML, BP-CML, and Ph+ALL Participants: Percentage of Participants With Major Molecular Response (MMR)</title>
          <description>MMR was defined as a ratio of reverse transcribed transcript of BCR-ABL to ABL &lt;=0.1% on the International scale (equivalent to a 3-log reduction in transcript). Participants were non-responders in any of the following situations: BCR-ABL or ABL levels not detectable at baseline, no valid baseline or post-baseline assessment, and baseline assessment for e1a2 variant only.</description>
          <population>Treated population included all participants who had received at least 1 dose of study drug.</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="1"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="1"/>
                <count group_id="O7" value="1"/>
                <count group_id="O8" value="2"/>
                <count group_id="O9" value="1"/>
                <count group_id="O10" value="11"/>
                <count group_id="O11" value="3"/>
                <count group_id="O12" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.0" upper_limit="97.5"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="97.5"/>
                    <measurement group_id="O3" value="0" lower_limit="0.0" upper_limit="60.2"/>
                    <measurement group_id="O4" value="100" lower_limit="29.2" upper_limit="100"/>
                    <measurement group_id="O5" value="0" lower_limit="0.0" upper_limit="97.5"/>
                    <measurement group_id="O6" value="0" lower_limit="0.0" upper_limit="97.5"/>
                    <measurement group_id="O7" value="0" lower_limit="0.0" upper_limit="97.5"/>
                    <measurement group_id="O8" value="50.0" lower_limit="1.3" upper_limit="98.7"/>
                    <measurement group_id="O9" value="9" lower_limit="0.0" upper_limit="97.5"/>
                    <measurement group_id="O10" value="27.3" lower_limit="6.0" upper_limit="61.0"/>
                    <measurement group_id="O11" value="33.3" lower_limit="0.8" upper_limit="90.6"/>
                    <measurement group_id="O12" value="0" lower_limit="0.0" upper_limit="45.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CP-CML, AP-CML, BP-CML, and Ph+ALL Participants: Median Time to Response (TTR)</title>
        <description>Time to response was defined as the interval from the first dose of study treatment until the criteria for response were first met, censored at the last assessment of response. Median time to response was estimated by Kaplan-Meier method.</description>
        <time_frame>From the first dose of study treatment until the criteria for response were first met (up to 60 months)</time_frame>
        <population>Treated population included all participants who had received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Ponatinib 30 mg: Phase 1 CP-CML</title>
            <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O2">
            <title>Ponatinib 30 mg: Phase 1 AP-CML</title>
            <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O3">
            <title>Ponatinib 30 mg: Phase 1 Ph+ ALL</title>
            <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O4">
            <title>Ponatinib 45 mg: Phase 1 CP-CML</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O5">
            <title>Ponatinib 45 mg: Phase 1 AP-CML</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O6">
            <title>Ponatinib 45 mg: Phase 1 BP-CML</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O7">
            <title>Ponatinib 45 mg: Phase 1 Ph+ ALL</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 in participant with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O8">
            <title>Ponatinib 15 mg: Phase 2 CP-CML</title>
            <description>Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).</description>
          </group>
          <group group_id="O9">
            <title>Ponatinib 15 mg: Phase 2 Ph+ ALL</title>
            <description>Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with Ph+ ALL resistant or intolerant to prior TKIs in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months).</description>
          </group>
          <group group_id="O10">
            <title>Ponatinib 45 mg: Phase 2 CP-CML</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.</description>
          </group>
          <group group_id="O11">
            <title>Ponatinib 45 mg: Phase 2 BP-CML</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.</description>
          </group>
          <group group_id="O12">
            <title>Ponatinib 45 mg: Phase 2 PH+ ALL</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with PH+ ALL resistant or intolerant to prior TKI in Expansion Phase 2.</description>
          </group>
        </group_list>
        <measure>
          <title>CP-CML, AP-CML, BP-CML, and Ph+ALL Participants: Median Time to Response (TTR)</title>
          <description>Time to response was defined as the interval from the first dose of study treatment until the criteria for response were first met, censored at the last assessment of response. Median time to response was estimated by Kaplan-Meier method.</description>
          <population>Treated population included all participants who had received at least 1 dose of study drug.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="1"/>
                <count group_id="O7" value="1"/>
                <count group_id="O8" value="2"/>
                <count group_id="O9" value="2"/>
                <count group_id="O10" value="11"/>
                <count group_id="O11" value="3"/>
                <count group_id="O12" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cytogenic response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.0" lower_limit="85" upper_limit="85"/>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O4" value="85" lower_limit="85" upper_limit="169"/>
                    <measurement group_id="O5" value="113" lower_limit="113" upper_limit="113"/>
                    <measurement group_id="O6" value="29" lower_limit="29" upper_limit="29"/>
                    <measurement group_id="O7" value="28" lower_limit="28" upper_limit="28"/>
                    <measurement group_id="O8" value="84" lower_limit="84" upper_limit="84"/>
                    <measurement group_id="O9" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O10" value="167" lower_limit="84" upper_limit="755"/>
                    <measurement group_id="O11" value="31" lower_limit="31" upper_limit="31"/>
                    <measurement group_id="O12" value="29" lower_limit="24" upper_limit="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematologic response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O2" value="22" lower_limit="22" upper_limit="22"/>
                    <measurement group_id="O3" value="14.5" lower_limit="14" upper_limit="15"/>
                    <measurement group_id="O4" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O5" value="56" lower_limit="56" upper_limit="56"/>
                    <measurement group_id="O6" value="15" lower_limit="15" upper_limit="15"/>
                    <measurement group_id="O7" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O8" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O9" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O10" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O11" value="17" lower_limit="17" upper_limit="17"/>
                    <measurement group_id="O12" value="15" lower_limit="10" upper_limit="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Molecular response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O4" value="85" lower_limit="85" upper_limit="421"/>
                    <measurement group_id="O5" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O6" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O7" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O8" value="84" lower_limit="84" upper_limit="84"/>
                    <measurement group_id="O9" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O10" value="253.0" lower_limit="84" upper_limit="842"/>
                    <measurement group_id="O11" value="58" lower_limit="58" upper_limit="58"/>
                    <measurement group_id="O12" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CP-CML and Advanced Phase Participants: Median Duration of Response (DOR)</title>
        <description>DOR: interval between first assessment at which criteria for response was met, until criteria for progression was met, censored at last date at which criteria for response was met. DOR was estimated using the Kaplan-Meier method. Progression criteria for CP was: death, development of AP/BP, or loss of CHR (in absence of cytogenic response), or loss of MCyR, or increasing WBC in participant without CHR (doubling of WBCs to &gt;20,000 on 2 occasions at least 4 weeks apart, after first week of therapy), as confirmed by development in complete blood cells (CBCs) at least 4 weeks apart; AP was: death, development of confirmed BP, loss of previous major/minor hematologic response over-2 week period, or no decrease from baseline levels in percentage blasts in peripheral blood/BM on all assessments over a 4-week period; and BP/Ph+ALL was: death/increasing blasts in peripheral blood or BM over a 4-week period. As planned, DOR is reported for all participants by entry mutation (T315I and Other).</description>
        <time_frame>From the first assessment at which criteria for response was met until the criteria for progression was first met (up to 60 months)</time_frame>
        <population>Treated population by entry mutation. Here number analyzed &quot;n&quot; are the participants who were evaluable for this outcome measure for given categories.</population>
        <group_list>
          <group group_id="O1">
            <title>Ponatinib 30 mg: Phase 1 CP-CML Participants With T315I Mutations</title>
            <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had (T)hreonine-315-(I)soleucine mutation (T315I) mutation of BCR-ABL in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O2">
            <title>Ponatinib 45 mg: Phase 1 CP-CML Participants With T315I Mutations</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O3">
            <title>Ponatinib 15 mg: Phase 2 CP-CML Participants With T315I Mutations</title>
            <description>Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had T315I mutation of BCR-ABL in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment Cycle for up to unacceptable drug reaction or disease progression (up to 60 months).</description>
          </group>
          <group group_id="O4">
            <title>Ponatinib 45 mg: Phase 2 CP-CML Participants With T315I Mutations</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had T315I mutation of BCR-ABL in Expansion Phase 2.</description>
          </group>
          <group group_id="O5">
            <title>Ponatinib 30 mg: Phase 1 CP-CML Participants With Other Mutations</title>
            <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants CP-CML resistant or intolerant to dasatinib or nilotinib and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O6">
            <title>Ponatinib 45 mg: Phase 1 CP-CML Participants With Other Mutations</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O7">
            <title>Ponatinib 15 mg: Phase 2 CP-CML Participants With Other Mutations</title>
            <description>Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).</description>
          </group>
          <group group_id="O8">
            <title>Ponatinib 45 mg: Phase 2 CP-CML Participants With Other Mutations</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.</description>
          </group>
          <group group_id="O9">
            <title>Ponatinib 30 mg: Phase 1 Advanced Phase Participants With T315I Mutations</title>
            <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O10">
            <title>Ponatinib 45 mg: Phase 1 Advanced Phase Participants With T315I Mutations</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O11">
            <title>Ponatinib 15 mg: Phase 2 Advanced Phase Participants With T315I Mutations</title>
            <description>Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.</description>
          </group>
          <group group_id="O12">
            <title>Ponatinib 45 mg: Phase 2 Advanced Phase Participants With T315I Mutations</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.</description>
          </group>
          <group group_id="O13">
            <title>Ponatinib 30 mg: Phase 1 Advanced Phase Participants With Other Mutations</title>
            <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O14">
            <title>Ponatinib 45 mg: Phase 1 Advanced Phase Participants With Other Mutations</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O15">
            <title>Ponatinib 15 mg: Phase 2 Advanced Phase Participants With Other Mutations</title>
            <description>Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.</description>
          </group>
          <group group_id="O16">
            <title>Ponatinib 45 mg: Phase 2 Advanced Phase Participants With Other Mutations</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.</description>
          </group>
        </group_list>
        <measure>
          <title>CP-CML and Advanced Phase Participants: Median Duration of Response (DOR)</title>
          <description>DOR: interval between first assessment at which criteria for response was met, until criteria for progression was met, censored at last date at which criteria for response was met. DOR was estimated using the Kaplan-Meier method. Progression criteria for CP was: death, development of AP/BP, or loss of CHR (in absence of cytogenic response), or loss of MCyR, or increasing WBC in participant without CHR (doubling of WBCs to &gt;20,000 on 2 occasions at least 4 weeks apart, after first week of therapy), as confirmed by development in complete blood cells (CBCs) at least 4 weeks apart; AP was: death, development of confirmed BP, loss of previous major/minor hematologic response over-2 week period, or no decrease from baseline levels in percentage blasts in peripheral blood/BM on all assessments over a 4-week period; and BP/Ph+ALL was: death/increasing blasts in peripheral blood or BM over a 4-week period. As planned, DOR is reported for all participants by entry mutation (T315I and Other).</description>
          <population>Treated population by entry mutation. Here number analyzed &quot;n&quot; are the participants who were evaluable for this outcome measure for given categories.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="1"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="3"/>
                <count group_id="O7" value="2"/>
                <count group_id="O8" value="9"/>
                <count group_id="O9" value="2"/>
                <count group_id="O10" value="2"/>
                <count group_id="O11" value="0"/>
                <count group_id="O12" value="4"/>
                <count group_id="O13" value="1"/>
                <count group_id="O14" value="1"/>
                <count group_id="O15" value="0"/>
                <count group_id="O16" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cytogenic response</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="3"/>
                    <count group_id="O7" value="1"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="2"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="4"/>
                    <count group_id="O13" value="0"/>
                    <count group_id="O14" value="1"/>
                    <count group_id="O15" value="0"/>
                    <count group_id="O16" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1513.0" lower_limit="NA" upper_limit="NA">95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O4" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O6" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O7" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O8" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O10" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O12" value="31.0" lower_limit="20.0" upper_limit="NA">95% CI (upper limit) were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O14" value="169.0" lower_limit="NA" upper_limit="NA">95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O16" value="205.0" lower_limit="NA" upper_limit="NA">95% CI were not estimable as excessive participants were censored.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematologic response</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="3"/>
                    <count group_id="O7" value="2"/>
                    <count group_id="O8" value="9"/>
                    <count group_id="O9" value="2"/>
                    <count group_id="O10" value="1"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="4"/>
                    <count group_id="O13" value="1"/>
                    <count group_id="O14" value="1"/>
                    <count group_id="O15" value="0"/>
                    <count group_id="O16" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O4" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O6" value="NA" lower_limit="1226.0" upper_limit="NA">Median and 95% CI (upper limit) were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O7" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O8" value="NA" lower_limit="85.0" upper_limit="NA">Median and 95% CI (upper limit) were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O9" value="56.5" lower_limit="38.0" upper_limit="NA">95% CI (upper limit) were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O10" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O12" value="50.5" lower_limit="33.0" upper_limit="NA">95% CI (upper limit) were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O13" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O14" value="226.0" lower_limit="NA" upper_limit="NA">95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O16" value="113.5" lower_limit="110.0" upper_limit="NA">95% CI (upper limit) were not estimable as excessive participants were censored.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Molecular response</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="1"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="3"/>
                    <count group_id="O7" value="1"/>
                    <count group_id="O8" value="2"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="1"/>
                    <count group_id="O13" value="0"/>
                    <count group_id="O14" value="0"/>
                    <count group_id="O15" value="0"/>
                    <count group_id="O16" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O6" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O7" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O8" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O12" value="168.0" lower_limit="NA" upper_limit="NA">95% CI were not estimable as excessive participants were censored.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CP-CML and Advanced Phase Participants: Median Progression-free Survival (PFS)</title>
        <description>PFS: interval from the first dose of study treatment until the criteria for progression or death were met, censored at the last response assessment. PFS was estimated using the Kaplan-Meier method. Progression criteria for CP was: death, development of AP/BP, or loss of CHR (in absence of cytogenic response), or loss of MCyR, or increasing WBC in participant without CHR (doubling of WBCs to &gt;20,000 on 2 occasions at least 4 weeks apart, after first week of therapy), as confirmed by development in CBCs at least 4 weeks apart; AP was: death, development of confirmed BP, loss of previous major/minor hematologic response over-2 week period, or no decrease from baseline levels in percentage blasts in peripheral blood/BM on all assessments over a 4-week period; BP/Ph+ALL was: death or increasing blasts in peripheral blood or BM over a 4-week period. As planned, PFS is reported for all participants by entry mutation (T315I and Other).</description>
        <time_frame>From the first assessment at which criteria for response was met until the criteria for progression or death was met (up to 60 months)</time_frame>
        <population>Treated population by entry mutation. Here overall number analyzed &quot;N&quot; are the participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Ponatinib 30 mg: Phase 1 CP-CML Participants With T315I Mutations</title>
            <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O2">
            <title>Ponatinib 45 mg: Phase 1 CP-CML Participants With T315I Mutations</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O3">
            <title>Ponatinib 15 mg: Phase 2 CP-CML Participants With T315I Mutations</title>
            <description>Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had T315I mutation of BCR-ABL in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).</description>
          </group>
          <group group_id="O4">
            <title>Ponatinib 45 mg: Phase 2 CP-CML Participants With T315I Mutations</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had T315I mutation of BCR-ABL in Expansion Phase 2.</description>
          </group>
          <group group_id="O5">
            <title>Ponatinib 30 mg: Phase 1 CP-CML Participants With Other Mutations</title>
            <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants CP-CML resistant or intolerant to dasatinib or nilotinib and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O6">
            <title>Ponatinib 45 mg: Phase 1 CP-CML Participants With Other Mutations</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O7">
            <title>Ponatinib 15 mg: Phase 2 CP-CML Participants With Other Mutations</title>
            <description>Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).</description>
          </group>
          <group group_id="O8">
            <title>Ponatinib 45 mg: Phase 2 CP-CML Participants With Other Mutations</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.</description>
          </group>
          <group group_id="O9">
            <title>Ponatinib 30 mg: Phase 1 Advanced Phase Participants With T315I Mutations</title>
            <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O10">
            <title>Ponatinib 45 mg: Phase 1 Advanced Phase Participants With T315I Mutations</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O11">
            <title>Ponatinib 15 mg: Phase 2 Advanced Phase Participants With T315I Mutations</title>
            <description>Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.</description>
          </group>
          <group group_id="O12">
            <title>Ponatinib 45 mg: Phase 2 Advanced Phase Participants With T315I Mutations</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.</description>
          </group>
          <group group_id="O13">
            <title>Ponatinib 30 mg: Phase 1 Advanced Phase Participants With Other Mutations</title>
            <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O14">
            <title>Ponatinib 45 mg: Phase 1 Advanced Phase Participants With Other Mutations</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O15">
            <title>Ponatinib 15 mg: Phase 2 Advanced Phase Participants With Other Mutations</title>
            <description>Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.</description>
          </group>
          <group group_id="O16">
            <title>Phase 2: Ponatinib 45 mg, Advanced Phase Participants With Other Mutations</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment Cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.</description>
          </group>
        </group_list>
        <measure>
          <title>CP-CML and Advanced Phase Participants: Median Progression-free Survival (PFS)</title>
          <description>PFS: interval from the first dose of study treatment until the criteria for progression or death were met, censored at the last response assessment. PFS was estimated using the Kaplan-Meier method. Progression criteria for CP was: death, development of AP/BP, or loss of CHR (in absence of cytogenic response), or loss of MCyR, or increasing WBC in participant without CHR (doubling of WBCs to &gt;20,000 on 2 occasions at least 4 weeks apart, after first week of therapy), as confirmed by development in CBCs at least 4 weeks apart; AP was: death, development of confirmed BP, loss of previous major/minor hematologic response over-2 week period, or no decrease from baseline levels in percentage blasts in peripheral blood/BM on all assessments over a 4-week period; BP/Ph+ALL was: death or increasing blasts in peripheral blood or BM over a 4-week period. As planned, PFS is reported for all participants by entry mutation (T315I and Other).</description>
          <population>Treated population by entry mutation. Here overall number analyzed &quot;N&quot; are the participants who were evaluable for this outcome measure.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="3"/>
                <count group_id="O7" value="2"/>
                <count group_id="O8" value="9"/>
                <count group_id="O9" value="3"/>
                <count group_id="O10" value="2"/>
                <count group_id="O11" value="1"/>
                <count group_id="O12" value="5"/>
                <count group_id="O13" value="2"/>
                <count group_id="O14" value="1"/>
                <count group_id="O15" value="0"/>
                <count group_id="O16" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1597.0" lower_limit="NA" upper_limit="NA">95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O4" value="NA" lower_limit="85.0" upper_limit="NA">Median and 95% CI (upper limit) were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O6" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O7" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O8" value="NA" lower_limit="113.0" upper_limit="NA">Median and 95% CI (upper limit) were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O9" value="51.0" lower_limit="29.0" upper_limit="NA">95% CI (upper limit) were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O10" value="320.0" lower_limit="113.0" upper_limit="NA">95% CI (upper limit) were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O11" value="33.0" lower_limit="NA" upper_limit="NA">95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O12" value="100.0" lower_limit="10.0" upper_limit="NA">95% CI (upper limit) were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O13" value="56.5" lower_limit="10.0" upper_limit="NA">95% CI (upper limit) were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O14" value="281.0" lower_limit="NA" upper_limit="NA">95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O16" value="127.5" lower_limit="85.0" upper_limit="NA">95% CI (upper limit) were not estimable as excessive participants were censored.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CP-CML and Advanced Phase Participants: Overall Survival (OS)</title>
        <description>OS was defined as the interval from the first dose of study treatment until death, censored at the last date at which participant was known to be alive. Overall survival was estimated using the Kaplan-Meier method. As planned, OS is reported for all participants by entry mutation (T315I and Other).</description>
        <time_frame>From the first dose of study treatment until death (up to 60 months)</time_frame>
        <population>Treated population by entry mutation. Here overall number analyzed &quot;N&quot; are the participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Ponatinib 30 mg: Phase 1 CP-CML Participants With T315I Mutations</title>
            <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O2">
            <title>Ponatinib 45 mg: Phase 1 CP-CML Participants With T315I Mutations</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O3">
            <title>Ponatinib 15 mg: Phase 2 CP-CML Participants With T315I Mutations</title>
            <description>Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had T315I mutation of BCR-ABL in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).</description>
          </group>
          <group group_id="O4">
            <title>Ponatinib 45 mg: Phase 2 CP-CML Participants With T315I Mutations</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had T315I mutation of BCR-ABL in Expansion Phase 2.</description>
          </group>
          <group group_id="O5">
            <title>Ponatinib 30 mg: Phase 1 CP-CML Participants With Other Mutations</title>
            <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants CP-CML resistant or intolerant to dasatinib or nilotinib and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O6">
            <title>Ponatinib 45 mg: Phase 1 CP-CML Participants With Other Mutations</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O7">
            <title>Ponatinib 15 mg: Phase 2 CP-CML Participants With Other Mutations</title>
            <description>Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).</description>
          </group>
          <group group_id="O8">
            <title>Ponatinib 45 mg: Phase 2 CP-CML Participants With Other Mutations</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.</description>
          </group>
          <group group_id="O9">
            <title>Ponatinib 30 mg: Phase 1 Ponatinib 30 mg: Phase 1 Advanced Phase Participants With T315I Mutations</title>
            <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O10">
            <title>Ponatinib 45 mg: Phase 1 Advanced Phase Participants With T315I Mutations</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O11">
            <title>Ponatinib 15 mg: Phase 2 Advanced Phase Participants With T315I Mutations</title>
            <description>Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.</description>
          </group>
          <group group_id="O12">
            <title>Ponatinib 45 mg: Phase 2 Advanced Phase Participants With T315I Mutations</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.</description>
          </group>
          <group group_id="O13">
            <title>Ponatinib 30 mg: Phase 1 Advanced Phase Participants With Other Mutations</title>
            <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O14">
            <title>Ponatinib 45 mg: Phase 1 Advanced Phase Participants With Other Mutations</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.</description>
          </group>
          <group group_id="O15">
            <title>Ponatinib 15 mg: Phase 2 Advanced Phase Participants With Other Mutations</title>
            <description>Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.</description>
          </group>
          <group group_id="O16">
            <title>Ponatinib 45 mg: Phase 2 Advanced Phase Participants With Other Mutations</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.</description>
          </group>
        </group_list>
        <measure>
          <title>CP-CML and Advanced Phase Participants: Overall Survival (OS)</title>
          <description>OS was defined as the interval from the first dose of study treatment until death, censored at the last date at which participant was known to be alive. Overall survival was estimated using the Kaplan-Meier method. As planned, OS is reported for all participants by entry mutation (T315I and Other).</description>
          <population>Treated population by entry mutation. Here overall number analyzed &quot;N&quot; are the participants who were evaluable for this outcome measure.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="3"/>
                <count group_id="O7" value="2"/>
                <count group_id="O8" value="9"/>
                <count group_id="O9" value="3"/>
                <count group_id="O10" value="2"/>
                <count group_id="O11" value="1"/>
                <count group_id="O12" value="5"/>
                <count group_id="O13" value="2"/>
                <count group_id="O14" value="1"/>
                <count group_id="O15" value="0"/>
                <count group_id="O16" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O4" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O6" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O7" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O8" value="NA" lower_limit="1305.0" upper_limit="NA">Median and 95% CI (upper limit) were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O9" value="201.0" lower_limit="194.0" upper_limit="NA">95% CI (upper limit) were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O10" value="NA" lower_limit="527.0" upper_limit="NA">Median and 95% CI (upper limit) were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O11" value="109.0" lower_limit="NA" upper_limit="NA">95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O12" value="264.0" lower_limit="169.0" upper_limit="NA">95% CI (upper limit) were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O13" value="131.0" lower_limit="10.0" upper_limit="NA">95% CI (upper limit) were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O14" value="382.0" lower_limit="NA" upper_limit="NA">95% CI were not estimable as excessive participants were censored.</measurement>
                    <measurement group_id="O16" value="550.5" lower_limit="281.0" upper_limit="NA">95% CI (upper limit) were not estimable as excessive participants were censored.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cmax: Maximum Observed Plasma Concentration for Ponatinib</title>
        <time_frame>Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)</time_frame>
        <population>Treated population include all participants who had received at least 1 dose of study drug and for whom PK samples were collected. As planned, PK samples were analyzed per dose level.</population>
        <group_list>
          <group group_id="O1">
            <title>Ponatinib 15 mg</title>
            <description>Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment Cycle 1 before 15 mg was dose-escalated to recommended phase 2 dose (RP2D) in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.</description>
          </group>
          <group group_id="O2">
            <title>Ponatinib 30 mg</title>
            <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment Cycle 1 in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.</description>
          </group>
          <group group_id="O3">
            <title>Ponatinib 45 mg</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment Cycle 1 in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax: Maximum Observed Plasma Concentration for Ponatinib</title>
          <population>Treated population include all participants who had received at least 1 dose of study drug and for whom PK samples were collected. As planned, PK samples were analyzed per dose level.</population>
          <units>nanogram per milliliter (ng/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.67" spread="7.136"/>
                    <measurement group_id="O2" value="31.55" spread="9.072"/>
                    <measurement group_id="O3" value="89.13" spread="24.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tmax: Time to Reach the Cmax for Ponatinib</title>
        <time_frame>Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)</time_frame>
        <population>Treated population include all participants who had received at least 1 dose of study drug and for whom PK samples were collected. As planned, PK samples were analyzed per dose level.</population>
        <group_list>
          <group group_id="O1">
            <title>Ponatinib 15 mg</title>
            <description>Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment Cycle 1 before 15 mg was dose-escalated to RP2D in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.</description>
          </group>
          <group group_id="O2">
            <title>Ponatinib 30 mg</title>
            <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment Cycle 1 in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.</description>
          </group>
          <group group_id="O3">
            <title>Ponatinib 45 mg</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment Cycle 1 in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax: Time to Reach the Cmax for Ponatinib</title>
          <population>Treated population include all participants who had received at least 1 dose of study drug and for whom PK samples were collected. As planned, PK samples were analyzed per dose level.</population>
          <units>hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" lower_limit="4.0" upper_limit="6.2"/>
                    <measurement group_id="O2" value="6.75" lower_limit="3.9" upper_limit="8.1"/>
                    <measurement group_id="O3" value="5.00" lower_limit="4.0" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUC(0-24): Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose for Ponatinib</title>
        <time_frame>Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)</time_frame>
        <population>Treated population include all participants who had received at least 1 dose of study drug and for whom PK samples were collected. As planned, PK samples were analyzed per dose level.</population>
        <group_list>
          <group group_id="O1">
            <title>Ponatinib 15 mg</title>
            <description>Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment Cycle 1 before 15 mg was dose-escalated to RP2D in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.</description>
          </group>
          <group group_id="O2">
            <title>Ponatinib 30 mg</title>
            <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment Cycle 1 in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.</description>
          </group>
          <group group_id="O3">
            <title>Ponatinib 45 mg</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment Cycle 1 in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC(0-24): Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose for Ponatinib</title>
          <population>Treated population include all participants who had received at least 1 dose of study drug and for whom PK samples were collected. As planned, PK samples were analyzed per dose level.</population>
          <units>hour*nanogram per milliliter (h*ng/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="336.00" spread="129.55"/>
                    <measurement group_id="O2" value="495.98" spread="154.09"/>
                    <measurement group_id="O3" value="1385.5" spread="456.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>T1/2: Terminal Phase Elimination Half-life for Ponatinib</title>
        <time_frame>Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)</time_frame>
        <population>Treated population include all participants who had received at least 1 dose of study drug and for whom PK samples were collected. As planned, PK samples were analyzed per dose level.</population>
        <group_list>
          <group group_id="O1">
            <title>Ponatinib 15 mg</title>
            <description>Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment Cycle 1 before 15 mg was dose-escalated to RP2D in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.</description>
          </group>
          <group group_id="O2">
            <title>Ponatinib 30 mg</title>
            <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment Cycle 1 in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.</description>
          </group>
          <group group_id="O3">
            <title>Ponatinib 45 mg</title>
            <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment Cycle 1 in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.</description>
          </group>
        </group_list>
        <measure>
          <title>T1/2: Terminal Phase Elimination Half-life for Ponatinib</title>
          <population>Treated population include all participants who had received at least 1 dose of study drug and for whom PK samples were collected. As planned, PK samples were analyzed per dose level.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Data could not be calculated for t1/2 due to lack of PK time points beyond 24 hours post-dose.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Data could not be calculated for t1/2 due to lack of PK time points beyond 24 hours post-dose.</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">Data could not be calculated for t1/2 due to lack of PK time points beyond 24 hours post-dose.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months</time_frame>
      <desc>At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Ponatinib 30 mg: Phase 1 CP-CML</title>
          <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
        </group>
        <group group_id="E2">
          <title>Ponatinib 30 mg: Phase 1 AP-CML</title>
          <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
        </group>
        <group group_id="E3">
          <title>Ponatinib 30 mg: Phase 1 Ph+ ALL</title>
          <description>Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.</description>
        </group>
        <group group_id="E4">
          <title>Ponatinib 45 mg: Phase 1 CP-CML</title>
          <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
        </group>
        <group group_id="E5">
          <title>Ponatinib 45 mg: Phase 1 AP-CML</title>
          <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
        </group>
        <group group_id="E6">
          <title>Ponatinib 45 mg: Phase 1 BP-CML</title>
          <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.</description>
        </group>
        <group group_id="E7">
          <title>Ponatinib 45 mg: Phase 1 Ph+ ALL</title>
          <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.</description>
        </group>
        <group group_id="E8">
          <title>Ponatinib 15 mg: Phase 2 CP-CML</title>
          <description>Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).</description>
        </group>
        <group group_id="E9">
          <title>Ponatinib 15 mg: Phase 2 Ph+ ALL</title>
          <description>Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with Ph+ ALL resistant or intolerant to prior TKIs in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months).</description>
        </group>
        <group group_id="E10">
          <title>Ponatinib 45 mg: Phase 2 CP-CML</title>
          <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.</description>
        </group>
        <group group_id="E11">
          <title>Ponatinib 45 mg: Phase 2 BP-CML</title>
          <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.</description>
        </group>
        <group group_id="E12">
          <title>Ponatinib 45 mg: Phase 2 PH+ ALL</title>
          <description>Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with PH+ ALL resistant or intolerant to prior TKI in Expansion Phase 2.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (22.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="6" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="6" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Disseminated intravascular coagulation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Coronary artery occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Retinal vein occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diverticulum intestinal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Mechanical ileus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </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="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hepatic failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Enteritis infectious</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Pneumonia legionella</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Fluid retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Neoplasm progression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Laryngeal squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Brain stem infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </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="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Diabetic nephropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Genital haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory distress syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </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="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (22.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="11" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="6" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Eosinophilia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Disseminated intravascular coagulation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Nephrogenic anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Cardiac aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Cardiac discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Conjunctival haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>CONJUNCTIVITIS allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Corneal disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Macular degeneration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Uveitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Epigastric discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Proctalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Anal incontinence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Angular cheilitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Chronic gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Colitis ischaemic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Gingival pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hiatus hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Odynophagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Proctitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Tooth loss</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </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="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="6" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="5" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="3" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Face oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hyperthermia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hepatic steatosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Bacterial infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Conjunctivitis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Gastroenteritis norovirus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Gastrointestinal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Impetigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Ophthalmic herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Perirectal abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Pyoderma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Tinea infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Tinea pedis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </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="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Allergic transfusion reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Skin laceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Cystitis radiation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Post procedural inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Radiation skin injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Tooth avulsion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="7" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="3" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="3" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Blood uric acid increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Blood cholesterol increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Blood phosphorus increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Blood urea increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Brain natriuretic peptide increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Ejection fraction decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Electrocardiogram t wave inversion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Protein C decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Urine output decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Fluid retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hypertriglyceridaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Tumour lysis syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Blood cholesterol increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dyslipidaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hypouricaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Steroid diabetes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Limb discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Periarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Tumour associated fever</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Seborrhoeic keratosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Tumour pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Cerebral artery occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dementia alzheimers type</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hemiplegia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Parkinsons disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Post herpetic neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Trigeminal neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Anxiety disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Tubulointerstitial nephritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Calculus urinary</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hypertensive nephropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Urethral pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Gynaecomastia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Menstrual disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Metrorrhagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </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="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Sleep apnoea syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="4" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Drug eruption</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dermatitis acneiform</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Purpura</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Asteatosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Decubitus ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dermal cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dermatitis exfoliative generalised</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Eczema asteatotic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hyperkeratosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Nail discolouration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Papule</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Photosensitivity reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Rash generalised</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Seborrhoeic dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Skin exfoliation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="6" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="3" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Peripheral coldness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
              </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>The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Director</name_or_title>
      <organization>Takeda</organization>
      <phone>+1-877-825-3327</phone>
      <email>trialdisclosures@takeda.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/NCT01667133
org study id: AP24534-11-106
nct id: NCT01667133
lead sponsor: 
has dmc: No
The purpose of this study is to assess the safety and efficacy of ponatinib in Japanese
      patients with chronic myeloid leukemia (CML) who have experienced failure of dasatinib or
      nilotinib or with Ph+ acute lymphoblastic leukemia (ALL) following failure of prior tyrosine
      kinase inhibitors (TKIs).
This multi-center, phase 1/2, open-label study will consist of two phases. The first will be
      a dose escalation phase employing a modified 3+3 design with two dose cohorts (30mg and
      45mg). After 6 patients complete the first cycle in a cohort, safety events will be evaluated
      before opening the next dose cohort. Patients will continue on treatment as long as it is
      tolerated and disease progression has not occurred. Phase 2 will occur at the recommended
      dose determined in phase 1 in an additional 25 patients. Another 3 patients will be dosed at
      15mg for collection of pharmacokinetic data. These patients may also escalate to the
      recommended dose and be assessed for efficacy and safety as phase 2 patients.

      Efficacy measures include molecular, cytogenetic, and hematologic response rates at various
      time points; time to response; duration of response; and survival follow-up. Safety measures
      include routine physical and laboratory evaluations, adverse event monitoring, and ECGs.
      Other measures include mutation testing and molecular genetic assessment. Accrual is expected
      to take approximately 12 months, and patients will be followed for survival for up to 60
      months from the last dose of study drug; therefore, the estimated duration of the trial is 72
      months.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs) as a Measure of Safety Profile to Determine Recommended Dose of Ponatinib
time frame: Cycle 1 (Cycle length= 28 days)
description: DLT was evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 and was defined as any of the following events: 1. Grade greater than or equal to (>=) 3 non-hematologic, with the exception of medically controllable toxicities (example; nausea, vomiting, fatigue, electrolyte disturbances, hypersensitivity reactions) lasting <=3 days, but excluding alopecia; 2. Missed doses: >25% of planned ponatinib doses over 28 days due to AEs in the first cycle; 3. Febrile neutropenia (the occurrence of an ANC <500/microliter concurrently with a temperature elevation of >101 degree Fahrenheit), when neutropenia is not related to underlying acute leukemia, as defined hematologic toxicity: Dose-limiting hematologic toxicity is the occurrence of a Grade 4 cytopenia >28 days, not related to underlying disease according to the investigator. Bone marrow examination must demonstrate <5% cellularity.
measure: Phase 2, CP-CML Participants: Percentage of Participants With Major Cytogenetic Response (MCyR)
time frame: Baseline up to 60 months
description: MCyR was defined as percentage of participants who achieved a complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR) after the initiation of study treatment. Cytogenic response was the percentage of Philadelphia chromosome positive (Ph+) metaphases in bone marrow. CCyR: no Ph+ cells. PCyR: 1% to 35% Ph+ cells. Participants entering the study already in PCyR had to achieve a CCyR in order to be considered a success for the confirmed MCyR rate.
measure: Phase 2, BP-CML and Ph+ALL: Percentage of Participants With Major Hematologic Response (MaHR)
time frame: Baseline up to 60 months
description: MaHR was defined as percentage of participants with complete hematologic response (CHR) or no evidence of leukemia (NEL). MaHR response was confirmed by a peripheral blood complete blood count (CBC) and differential no earlier than 28 days after the response was observed. Response criteria for CHR was reported as white blood cells (WBC)<=institutional upper limit of normal (ULN), absolute neutrophil count (ANC)>=1000/mm^3, platelets>=100,000/mm^3, no blasts or promyelocytes in peripheral blood, BM blasts <=5%, <5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood <5%, no extramedullary involvement; Response criteria for NEL reported as WBC<=institutional ULN, no blasts or promyelocytes in peripheral blood, BM blasts <=5%, <5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood <5%, no extramedullary involvement, at least 1 of the following: (i) 20,000/mm^3<=platelets<100,000/mm^3; (ii) 500/mm^3<=ANC<1000/mm^3.
measure: CP-CML Participants: Percentage of Participants With CHR
time frame: Baseline up to 60 months
description: Hematologic response was defined as CHR for CP-CML participants. Participants who entered the trial in CHR and continued to meet the criteria for CHR on study were analyzed as responders. Response criteria for CHR was reported as WBC <=institutional ULN, platelets <450,000 per cubic millimeter (/mm^3), no blasts or promyelocytes in peripheral blood, <5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood <5%, no extramedullary involvement (including no hepatomegaly or splenomegaly).
measure: CP-CML, AP-CML, BP-CML, and Ph+ALL Participants: Percentage of Participants With Confirmed MCyR
time frame: Baseline up to 60 months
description: Confirmed MCyR was defined as 2 assessments of CCyR or PCyR at least 28 days apart. Participants entering the trial in PCyR must achieve two consecutive assessments of CCyR no fewer than 28 days apart in order to be considered as meeting the criteria for confirmed MCyR. Participants entering the trial in less than PCyR must achieve two consecutive assessments of PCyR or CCyR no fewer than 28 days apart in order to be considered as meeting the criteria for confirmed MCyR. CCyR: no Ph+ cells. PCyR: 1% to 35% Ph+ cells.
measure: CP-CML, AP-CML, BP-CML, and Ph+ALL Participants: Percentage of Participants With Major Molecular Response (MMR)
time frame: Baseline up to 60 months
description: MMR was defined as a ratio of reverse transcribed transcript of BCR-ABL to ABL <=0.1% on the International scale (equivalent to a 3-log reduction in transcript). Participants were non-responders in any of the following situations: BCR-ABL or ABL levels not detectable at baseline, no valid baseline or post-baseline assessment, and baseline assessment for e1a2 variant only.
measure: CP-CML, AP-CML, BP-CML, and Ph+ALL Participants: Median Time to Response (TTR)
time frame: From the first dose of study treatment until the criteria for response were first met (up to 60 months)
description: Time to response was defined as the interval from the first dose of study treatment until the criteria for response were first met, censored at the last assessment of response. Median time to response was estimated by Kaplan-Meier method.
measure: CP-CML and Advanced Phase Participants: Median Duration of Response (DOR)
time frame: From the first assessment at which criteria for response was met until the criteria for progression was first met (up to 60 months)
description: DOR: interval between first assessment at which criteria for response was met, until criteria for progression was met, censored at last date at which criteria for response was met. DOR was estimated using the Kaplan-Meier method. Progression criteria for CP was: death, development of AP/BP, or loss of CHR (in absence of cytogenic response), or loss of MCyR, or increasing WBC in participant without CHR (doubling of WBCs to >20,000 on 2 occasions at least 4 weeks apart, after first week of therapy), as confirmed by development in complete blood cells (CBCs) at least 4 weeks apart; AP was: death, development of confirmed BP, loss of previous major/minor hematologic response over-2 week period, or no decrease from baseline levels in percentage blasts in peripheral blood/BM on all assessments over a 4-week period; and BP/Ph+ALL was: death/increasing blasts in peripheral blood or BM over a 4-week period. As planned, DOR is reported for all participants by entry mutation (T315I and Other).
measure: CP-CML and Advanced Phase Participants: Median Progression-free Survival (PFS)
time frame: From the first assessment at which criteria for response was met until the criteria for progression or death was met (up to 60 months)
description: PFS: interval from the first dose of study treatment until the criteria for progression or death were met, censored at the last response assessment. PFS was estimated using the Kaplan-Meier method. Progression criteria for CP was: death, development of AP/BP, or loss of CHR (in absence of cytogenic response), or loss of MCyR, or increasing WBC in participant without CHR (doubling of WBCs to >20,000 on 2 occasions at least 4 weeks apart, after first week of therapy), as confirmed by development in CBCs at least 4 weeks apart; AP was: death, development of confirmed BP, loss of previous major/minor hematologic response over-2 week period, or no decrease from baseline levels in percentage blasts in peripheral blood/BM on all assessments over a 4-week period; BP/Ph+ALL was: death or increasing blasts in peripheral blood or BM over a 4-week period. As planned, PFS is reported for all participants by entry mutation (T315I and Other).
measure: CP-CML and Advanced Phase Participants: Overall Survival (OS)
time frame: From the first dose of study treatment until death (up to 60 months)
description: OS was defined as the interval from the first dose of study treatment until death, censored at the last date at which participant was known to be alive. Overall survival was estimated using the Kaplan-Meier method. As planned, OS is reported for all participants by entry mutation (T315I and Other).
measure: Cmax: Maximum Observed Plasma Concentration for Ponatinib
time frame: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)
measure: Tmax: Time to Reach the Cmax for Ponatinib
time frame: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)
measure: AUC(0-24): Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose for Ponatinib
time frame: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)
measure: T1/2: Terminal Phase Elimination Half-life for Ponatinib
time frame: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)
arm group label: Phase 1 dose escalation
arm group type: Experimental
description: Phase 1
arm group label: Phase 2 expansion
arm group type: Experimental
description: Phase 2
intervention type: Drug
intervention name: ponatinib - Phase 1
description: 30 mg dose of ponatinib taken orally once daily for at least the first 6 patients. If no dose-limiting toxicities are observed, the next patients will receive 45 mg dose of ponatinib taken orally once daily. Once the recommended dose is confirmed, all patients may receive the recommended dose, at the investigators' discretion.
arm group label: Phase 1 dose escalation
other name: AP24534
intervention type: Drug
intervention name: ponatinib - Phase 2
description: Recommended dose of ponatinib as determined in the dose escalation phase. In addition, 3 patients will receive 15 mg dose once daily for 8 days for PK testing. These PK patients may be allowed to receive the recommended dose after PK testing is complete, at the investigators' discretion.
arm group label: Phase 2 expansion
other name: AP24534
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Takeda
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Leukemia, Lymphoid
mesh term: Leukemia, Myelogenous, Chronic, BCR-ABL Positive
mesh term: Philadelphia Chromosome
mesh term: Ponatinib
sharing ipd: Yes
ipd description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
ipd url: https://vivli.org/ourmember/takeda/
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 