<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/NCT02970318</url>
  </required_header>
  <id_info>
    <org_study_id>ACE-CL-309</org_study_id>
    <secondary_id>2015-004454-17</secondary_id>
    <nct_id>NCT02970318</nct_id>
  </id_info>
  <brief_title>A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL</brief_title>
  <official_title>A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator's Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects With R/R Chronic Lymphocytic Leukemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Acerta Pharma BV</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Acerta Pharma BV</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to evaluate the efficacy of acalabrutinib compared with rituximab in&#xD;
      combination with idelalisib or bendamustine in previously treated subjects with chronic&#xD;
      lymphocytic leukemia (CLL).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 2, 2017</start_date>
  <completion_date type="Anticipated">September 3, 2027</completion_date>
  <primary_completion_date type="Actual">September 3, 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free Survival (PFS) Per Independent Review Committee (IRC) Assessment</measure>
    <time_frame>IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up</time_frame>
    <description>To evaluate the efficacy of acalabrutinib monotherapy (Arm A) compared with idelalisib/rituximab or bendamustine/rituximab (Arm B) based on Independent Review Committee (IRC) assessment of progression-free survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria (Hallek 2008) with incorporation of the clarification for treatment-related lymphocytosis (Cheson 2012) hereafter referred to as IWCLL 2008 criteria in subjects with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). As planned and reported in the interim clinical study report (dated 17 July 2019), because the study did cross the boundary at interim analysis.&#xD;
IRC assessments were discontinued after the interim analysis. All IRC-related efficacy analyses in this clinical study report were based on the interim analysis data cutoff date of 15 January 2019. All other efficacy analyses were based on the final analysis data cutoff date of 03 September 2021.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival (PFS) Per Investigator Assessment</measure>
    <time_frame>From randomization date to date of disease progression or death due to any cause or data cutoff date on 03Sep2021, whichever came first, regardless of use of subsequent anticancer therapy, until 53 months of follow-up.</time_frame>
    <description>PFS per investigator assessment based on the final analysis data cutoff date of 03 September 2021.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IRC-assessed Overall Response Rate (ORR) Per IWCLL 2008 Criteria Based on Data Cutoff 15 January 2019 From Interim Analysis</measure>
    <time_frame>IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up</time_frame>
    <description>IRC-assessed overall response rate (ORR) including complete response (CR), CR with incomplete blood count recovery (CRi) nodular PR (nPR), and Partial Response (PR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator Assessed Overall Response Rate (ORR) Per IWCLL 2008 Criteria Based on Data Cutoff 03 September 2021</measure>
    <time_frame>Investigator assessments were done from randomization date until date of death or date of exit from study or data cut off date on 03Sep2021, whichever came first, up to 53 months of follow-up.</time_frame>
    <description>IRC-assessed overall response rate (ORR) including complete response (CR), CR with incomplete blood count recovery (CRi) nodular PR (nPR), and Partial Response (PR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>From randomization date to date of death due to any cause, or date of study discontinuation, or date of data cutoff on 03Sep2021, whichever came first until 54 months of follow-up.</time_frame>
    <description>Overall Survival (OS) was based on data cutoff date of 03Sep2021</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR) Per Independent Review Committee (IRC) Assessment Based on 15 January 2019 Data Cutoff From Interim Analysis.</measure>
    <time_frame>IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up</time_frame>
    <description>Duration of Response (DOR) is defined as from the first documentation of CR, CRi, PR, or nPR to the earlier of the first documentation of disease progression or death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR) Per Investigator Assessment Based on 03 September 2021 Data Cutoff</measure>
    <time_frame>Investigator assessments were done from randomization date until date of death or study discontinuation or data cutoff date on 03Sep2021, whichever came first up to 53 months of follow-up.</time_frame>
    <description>Duration of Response (DOR) is defined as from the first documentation of CR, CRi, PR, or nPR to the earlier of the first documentation of disease progression or death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Next Treatment (TTNT) Based on 03 September 2021 Data Cutoff</measure>
    <time_frame>From randomization date to start of non-protocol specified subsequent anticancer therapy for CLL or death due to any cause or study discontinuation or data cutoff date on 03Sep2021,, whichever came first up to 53 months of follow-up.</time_frame>
    <description>Time to Next Treatment (TTNT) is defined as the time from date of randomization to date of institution of non-protocol-specified treatment for CLL (or first dose date of acalabrutinib for Arm B subjects crossing over to receive acalabrutinib) or death due to any cause, whichever comes first.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">310</enrollment>
  <condition>Chronic Lymphocytic Leukemia</condition>
  <arm_group>
    <arm_group_label>Acalabrutinib (ACP-196)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acalabrutinib (ACP-196) Monotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rituximab Plus Idelalisib or Bendamustine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Investigator's Choice of Rituximab Plus Idelalisib or Bendamustine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acalabrutinib (ACP-196)</intervention_name>
    <description>Acalabrutinib monotherapy</description>
    <arm_group_label>Acalabrutinib (ACP-196)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>Rituximab in combination with idelalisib or bendamustine</description>
    <arm_group_label>Rituximab Plus Idelalisib or Bendamustine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Idelalisib</intervention_name>
    <description>Idelalisib in combination with rituximab</description>
    <arm_group_label>Rituximab Plus Idelalisib or Bendamustine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bendamustine</intervention_name>
    <description>Bendamustine in combination with rituximab</description>
    <arm_group_label>Rituximab Plus Idelalisib or Bendamustine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women ≥ 18 years of age.&#xD;
&#xD;
          2. ECOG performance status of 0 to 2.&#xD;
&#xD;
          3. Diagnosis of CLL that meets published diagnostic criteria (Hallek 2008):&#xD;
&#xD;
               1. Monoclonal B-cells (either kappa or lambda light chain restricted) that are&#xD;
                  clonally co-expressing ≥ 1 B-cell marker (CD19, CD20, or CD23) and CD5.&#xD;
&#xD;
               2. Prolymphocytes may comprise ≤ 55% of blood lymphocytes.&#xD;
&#xD;
               3. Presence of ≥ 5 x 10^9 B lymphocytes/L (5000/μL) in the peripheral blood (at any&#xD;
                  point since initial diagnosis).&#xD;
&#xD;
          4. Must have documented CD20-positive CLL.&#xD;
&#xD;
          5. Active disease meeting ≥ 1 of the following IWCLL 2008 criteria for requiring&#xD;
             treatment:&#xD;
&#xD;
               1. Evidence of progressive marrow failure as manifested by the development of, or&#xD;
                  worsening of, anemia (hemoglobin &lt; 10 g/dL) and/or thrombocytopenia (platelets &lt;&#xD;
                  100,000/μL).&#xD;
&#xD;
               2. Massive (i.e., ≥ 6 cm below the left costal margin), progressive, or symptomatic&#xD;
                  splenomegaly.&#xD;
&#xD;
               3. Massive nodes (i.e., ≥ 10 cm in the longest diameter), progressive, or&#xD;
                  symptomatic lymphadenopathy.&#xD;
&#xD;
               4. Progressive lymphocytosis with an increase of &gt; 50% over a 2-month period or a&#xD;
                  LDT of &lt; 6 months. LDT may be obtained by linear regression extrapolation of ALC&#xD;
                  obtained at intervals of 2 weeks over an observation period of 2 to 3 months. In&#xD;
                  subjects with initial blood lymphocyte counts of &lt; 30 x 10^9/L (30,000/μL), LDT&#xD;
                  should not be used as a single parameter to define indication for treatment. In&#xD;
                  addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL&#xD;
                  (e.g., infections) should be excluded.&#xD;
&#xD;
               5. Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard&#xD;
                  therapy.&#xD;
&#xD;
               6. Constitutional symptoms documented in the subject's chart with supportive&#xD;
                  objective measures, as appropriate, defined as ≥ 1 of the following&#xD;
                  disease-related symptoms or signs:&#xD;
&#xD;
             i. Unintentional weight loss ≥ 10% within the previous 6 months before screening.&#xD;
&#xD;
             ii. Significant fatigue (ECOG performance score 2; inability to work or perform usual&#xD;
             activities).&#xD;
&#xD;
             iii. Fevers higher than 100.5°F or 38.0°C for ≥ 2 weeks before screening without&#xD;
             evidence of infection.&#xD;
&#xD;
             iv. Night sweats for &gt; 1 month before screening without evidence of infection.&#xD;
&#xD;
          6. Meet the following laboratory parameters:&#xD;
&#xD;
               1. ANC ≥ 750 cells/μL (0.75 x 10^9/L), or ≥ 500 cells/μL (0.50 x 10^9/L) in subjects&#xD;
                  with documented bone marrow involvement, and independent of growth factor support&#xD;
                  7 days before assessment.&#xD;
&#xD;
               2. Platelet count ≥ 50,000 cells/μL (50 x 10^9/L), or ≥ 30,000 cells/μL (30 x&#xD;
                  10^9/L) in subjects with documented bone marrow involvement, and without&#xD;
                  transfusion support 7 days before assessment. Subjects with transfusion-dependent&#xD;
                  thrombocytopenia are excluded. If an Investigator has chosen&#xD;
                  bendamustine/rituximab as the Arm B treatment, platelets must be ≥ 75,000&#xD;
                  cells/μL (75 x 10^9/L).&#xD;
&#xD;
               3. Serum AST and ALT ≤ 2.0 x ULN.&#xD;
&#xD;
               4. Total bilirubin ≤ 1.5 x ULN.&#xD;
&#xD;
               5. Estimated creatinine clearance of ≥ 30 mL/min, calculated using the formula of&#xD;
                  Cockcroft and Gault [(140-Age) • Mass (kg)/(72 • creatinine mg/dL); multiply by&#xD;
                  0.85 if female].&#xD;
&#xD;
          7. Must have received ≥ 1 prior systemic therapies for CLL. Note: Single-agent steroids&#xD;
             or localized radiation are not considered a prior line of therapy. If a single-agent&#xD;
             anti-CD20 antibody was previously administered, subjects must have received ≥ 2 doses.&#xD;
&#xD;
          8. Women who are sexually active and can bear children must agree to use highly effective&#xD;
             forms of contraception while on the study and for 2 days after the last dose of&#xD;
             acalabrutinib, 90 days after the last dose of idelalisib, 6 months after the last dose&#xD;
             of bendamustine, or 12 months after the last dose of rituximab, whichever is longer.&#xD;
             Highly effective forms of contraception are defined in Section 9.2.5.&#xD;
&#xD;
          9. Men who are sexually active and can beget children must agree to use highly effective&#xD;
             forms of contraception during the study and for 90 days after the last dose of&#xD;
             idelalisib, 6 months after the last dose of bendamustine, or 12 months after the last&#xD;
             dose of rituximab, whichever is longer. Highly effective forms of contraception are&#xD;
             defined in Section 9.2.5.&#xD;
&#xD;
         10. Men must agree to refrain from sperm donation during the study and for 90 days after&#xD;
             the last dose of idelalisib, 6 months after the last dose of bendamustine, or 12&#xD;
             months after the last dose of rituximab, whichever is longer.&#xD;
&#xD;
         11. Willing and able to participate in all required evaluations and procedures in this&#xD;
             study protocol, including swallowing capsules without difficulty.&#xD;
&#xD;
         12. Ability to understand the purpose and risks of the study and provide signed and dated&#xD;
             informed consent and authorization to use protected health information (in accordance&#xD;
             with national and local patient privacy regulations).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known CNS lymphoma or leukemia.&#xD;
&#xD;
          2. Known prolymphocytic leukemia or history of, or currently suspected, Richter's&#xD;
             syndrome.&#xD;
&#xD;
          3. Uncontrolled AIHA or ITP defined as declining hemoglobin or platelet count secondary&#xD;
             to autoimmune destruction within the screening period or requirement for high doses of&#xD;
             steroids (&gt; 20 mg daily of prednisone or equivalent).&#xD;
&#xD;
          4. Prior exposure to a BCL-2 inhibitor (e.g., venetoclax/ABT-199) or a BCR inhibitor&#xD;
             (e.g., BTK inhibitors or PI3K inhibitors). Prior bendamustine is allowed if&#xD;
             Investigator's choice for treatment in Arm B is idelalisib with rituximab.&#xD;
             Bendamustine retreatment is allowed if the prior response to bendamustine lasted &gt; 24&#xD;
             months.&#xD;
&#xD;
          5. Received any chemotherapy, external beam radiation therapy, anticancer antibodies, or&#xD;
             investigational drug within 30 days before first dose of study drug.&#xD;
&#xD;
          6. Corticosteroid use &gt; 20 mg daily prednisone equivalent within 1 week before first dose&#xD;
             of study drug, except as indicated for other medical conditions such as inhaled&#xD;
             steroid for asthma, topical steroid use, or as premedication for administration of&#xD;
             study drug or contrast. For example, subjects requiring steroids at daily doses &gt; 20&#xD;
             mg prednisone equivalent systemic exposure daily, or those who are administered&#xD;
             steroids for leukemia control or white blood cell count lowering are excluded.&#xD;
&#xD;
          7. Prior radio- or toxin-conjugated antibody therapy.&#xD;
&#xD;
          8. Prior allogeneic stem cell transplant or prior autologous transplant within 6 months&#xD;
             of first dose of study drug(s) or presence of graft-vs-host disease or receiving&#xD;
             treatment for graft-vs-host disease.&#xD;
&#xD;
          9. Major surgical procedure within 30 days of first dose of study drug. Note: If a&#xD;
             subject had major surgery, they must have recovered adequately from any toxicity&#xD;
             and/or complications from the intervention before the first dose of study drug.&#xD;
&#xD;
         10. History of prior malignancy except for the following:&#xD;
&#xD;
               1. Malignancy treated with curative intent and with no evidence of active disease&#xD;
                  present for more than 2 years before screening and felt to be at low risk for&#xD;
                  recurrence by treating physician.&#xD;
&#xD;
               2. Adequately treated lentigo maligna melanoma without current evidence of disease&#xD;
                  or adequately controlled nonmelanomatous skin cancer.&#xD;
&#xD;
               3. Adequately treated carcinoma in situ without current evidence of disease.&#xD;
&#xD;
         11. Significant cardiovascular disease such as uncontrolled or untreated symptomatic&#xD;
             arrhythmias, congestive heart failure, or myocardial infarction within 6 months of&#xD;
             screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart&#xD;
             Association Functional Classification, or QTc &gt; 480 msec (calculated using&#xD;
             Fridericia's formula: QT/RR^0.33) at screening. Exception: Subjects with controlled,&#xD;
             asymptomatic atrial fibrillation during screening are allowed to enroll on study.&#xD;
&#xD;
         12. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or&#xD;
             resection of the stomach, or extensive small bowel resection that is likely to affect&#xD;
             absorption, symptomatic inflammatory bowel disease, or partial or complete bowel&#xD;
             obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.&#xD;
&#xD;
         13. Received a live virus vaccination within 28 days of first dose of study drug.&#xD;
&#xD;
         14. Known history of infection with HIV or any uncontrolled active systemic infection&#xD;
             (e.g., bacterial, viral, or fungal). For study sites in Germany: active infection with&#xD;
             human immunodeficiency virus (seropositivity for HIV-1 or HIV-2 antibodies, and if&#xD;
             positive, reactivity against the HIV-specific p24 antigen).&#xD;
&#xD;
         15. Active CMV infection (active viremia as evidenced by positive polymerase chain&#xD;
             reaction [PCR] result for CMV DNA).&#xD;
&#xD;
         16. Serologic status reflecting active hepatitis B or C infection.&#xD;
&#xD;
               1. Subjects who are anti-HBc positive and who are surface antigen negative will need&#xD;
                  to have a negative PCR result before randomization. Those who are HbsAg-positive&#xD;
                  or hepatitis B PCR positive will be excluded.&#xD;
&#xD;
               2. Subjects who are hepatitis C antibody positive will need to have a negative PCR&#xD;
                  result before randomization. Those who are hepatitis C PCR positive will be&#xD;
                  excluded.&#xD;
&#xD;
         17. Ongoing, drug-induced liver injury, alcoholic liver disease, non-alcoholic&#xD;
             steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by&#xD;
             cholelithiasis, cirrhosis of the liver, or portal hypertension.&#xD;
&#xD;
         18. History of or ongoing drug-induced pneumonitis.&#xD;
&#xD;
         19. History of serious allergic reactions including anaphylaxis and toxic epidermal&#xD;
             necrolysis.&#xD;
&#xD;
         20. History of stroke or intracranial hemorrhage within 6 months before first dose of&#xD;
             study drug.&#xD;
&#xD;
         21. History of bleeding diathesis (e.g., hemophilia, von Willebrand disease).&#xD;
&#xD;
         22. Requires or receiving anticoagulation with warfarin or equivalent vitamin K&#xD;
             antagonists (e.g., phenprocoumon) within 7 days of first dose of study drug.&#xD;
&#xD;
         23. Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before&#xD;
             screening.&#xD;
&#xD;
         24. Requires treatment with a strong CYP3A inhibitor/inducer.&#xD;
&#xD;
         25. Requires treatment with proton-pump inhibitors (e.g., omeprazole, esomeprazole,&#xD;
             lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving&#xD;
             proton-pump inhibitors who switch to H2-receptor antagonists or antacids are eligible&#xD;
             for enrollment to this study.&#xD;
&#xD;
         26. Breast feeding or pregnant.&#xD;
&#xD;
         27. Concurrent participation in another therapeutic clinical trial.&#xD;
&#xD;
         28. Prothrombin time/INR or aPTT (in the absence of a Lupus anticoagulant) &gt; 2.0 x ULN.&#xD;
             Exception: Subjects receiving warfarin are excluded, however, those receiving other&#xD;
             anticoagulant therapy who have a higher INR/aPTT may be permitted to enroll to this&#xD;
             study after discussion with the medical monitor.&#xD;
&#xD;
         29. History of confirmed progressive multifocal leukoencephalopathy (PML)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Acerta Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>1-888-292-9613; acertamc@dlss.com</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oxnard</city>
        <state>California</state>
        <zip>93030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Athens</city>
        <state>Georgia</state>
        <zip>30607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Joliet</city>
        <state>Illinois</state>
        <zip>60435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cedar Rapids</city>
        <state>Iowa</state>
        <zip>52403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mount Sterling</city>
        <state>Kentucky</state>
        <zip>40353</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saint Cloud</city>
        <state>Minnesota</state>
        <zip>56303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brick</city>
        <state>New Jersey</state>
        <zip>08724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nyack</city>
        <state>New York</state>
        <zip>10960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44719</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fort Sam Houston</city>
        <state>Texas</state>
        <zip>78234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Round Rock</city>
        <state>Texas</state>
        <zip>78665</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Adelaide</city>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Box Hill</city>
        <zip>3128</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Frankston</city>
        <zip>3199</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Geelong</city>
        <zip>3220</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gosford</city>
        <zip>2250</zip>
        <country>Australia</country>
      </address>
    </facility>
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        <zip>040 01</zip>
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      <address>
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        <city>Wolverhampton</city>
        <zip>WV10 0QP</zip>
        <country>United Kingdom</country>
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  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Croatia</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hong Kong</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>New Zealand</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Singapore</country>
    <country>Slovakia</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Taiwan</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Turkey</country>
  </removed_countries>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=ACE-CL-309&amp;amp;attachmentIdentifier=4d2fac79-d899-4138-8657-0bb2b540784b&amp;amp;fileName=ace-cl-309-csp-amend-8-redact.pdf&amp;amp;versionIdentifier=</url>
    <description>Redacted CSP</description>
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  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=ACE-CL-309&amp;amp;attachmentIdentifier=5ba8b7a4-ac40-4f7a-b333-9c025218e080&amp;amp;fileName=ace-cl-309-sap-ed-3-redact.pdf&amp;amp;versionIdentifier=</url>
    <description>Redacted SAP</description>
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  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=ACE-CL-309&amp;amp;attachmentIdentifier=aa63aaa7-e136-4da4-89c9-2ad21beb4457&amp;amp;fileName=ace-cl-309-Study_Synopsis-redact.pdf&amp;amp;versionIdentifier=</url>
    <description>Redacted CSR synopsis</description>
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  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <results_first_submitted>September 2, 2022</results_first_submitted>
  <results_first_submitted_qc>June 28, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 29, 2023</results_first_posted>
  <last_update_submitted>June 28, 2023</last_update_submitted>
  <last_update_submitted_qc>June 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CLL</keyword>
  <keyword>BTK</keyword>
  <keyword>Bruton Tyrosine Kinase</keyword>
  <keyword>acalabrutinib</keyword>
  <keyword>ACP-196</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
    <mesh_term>Leukemia, Lymphocytic, Chronic, B-Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rituximab</mesh_term>
    <mesh_term>Bendamustine Hydrochloride</mesh_term>
    <mesh_term>Acalabrutinib</mesh_term>
    <mesh_term>Idelalisib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.&#xD;
All request will be evaluated as per the AZ disclosure commitment:&#xD;
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_time_frame>
    <ipd_access_criteria>When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_access_criteria>
    <ipd_url>https://astrazenecagroup-dt.pharmacm.com/DT/Home</ipd_url>
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  <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>May 26, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT02970318/Prot_002.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 6, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT02970318/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator's Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia. A total of 310 subjects met the eligibility criteria and were randomized to the acalabrutinib arm (N = 155) and IR/BR arm (N = 155).&#xD;
All but 3 subjects (1 randomized to acalabrutinib and 2 randomized to IR/BR) received study treatment.</recruitment_details>
      <pre_assignment_details>310 patients were enrolled in this study and agreed to move forward in participating in the trial.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Arm A- Acala 100 mg BID- Overall Study Period</title>
          <description>Arm A- Acalabrutinib 100 mg BID- Overall Study Period</description>
        </group>
        <group group_id="P2">
          <title>Arm B: Investigator Choice (IR or BR)-Main Study Period</title>
          <description>IR or BR data not presented separately similar to combined treatment arms approved for D8223C00009</description>
        </group>
        <group group_id="P3">
          <title>Arm B- Inv Choice of IR Crossed Over to Arm A- Acala. 100 mg BID</title>
          <description>Arm B- Investigator Choice of IR Crossed Over to Arm A- Acala. 100 mg BID</description>
        </group>
        <group group_id="P4">
          <title>Arm B- Inv. Choice of BR Crossed Over to Arm A- Acala. 100 mg BID</title>
          <description>Arm B- Investigator Choice of BR Crossed Over to Arm A- Acala. 100 mg BID</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall for Arm A &amp; Main for Arm B</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="155"/>
                <participants group_id="P2" count="155"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Arm B Treatment= Idelalisib Plus Rituximab</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="119"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Arm B Treatment = Bendamustine Plus Rituximab</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="36"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1">This subject received 1st dose of study drug on 11Nov2011, completed study treatment on 14MAR2019, never crossed over, and and died 11 months after completing study treatment on 15Feb2020.</participants>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed</title>
              <participants_list>
                <participants group_id="P1" count="99"/>
                <participants group_id="P2" count="26"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="99">All 99 subjects ongoing treatment at final DCO.</participants>
                <participants group_id="P2" count="27">26 subjects ongoing treatment + 1 subject completed study treatment and died 11 months after completing study treatment on 15Feb2020.</participants>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
                <participants group_id="P2" count="128"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="33"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Arm B Crossed Over to Arm A Acala 100 mg Monotherapy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="80"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>ArmB: Inv.Choice Crossed Over to Acala</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0">N/A. Note: No subjects stayed in Arm: Investigator's choice of IR/BR during cross-over period.</participants>
                <participants group_id="P3" count="63">Note: There were a total of 80 subjects in Arm B crossing over to Arm A shown under the last row of Main Study Period. Among them 63 were randomized to Arm B: IR and 17 were randomized to BR.</participants>
                <participants group_id="P4" count="17">Note: There were a total of 80 subjects in Arm B crossing over to Arm A shown under the last row of Main Study Period. Among them 63 were randomized to Arm B: IR and 17 were randomized to BR.</participants>
              </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="42"/>
                <participants group_id="P4" count="14"/>
              </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="21"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" 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="1"/>
                <participants group_id="P4" count="1"/>
              </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="18"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analysis was performed on Intent-to-Treat (ITT) population, which included all randomized participants grouped according to assigned treatment.</population>
      <group_list>
        <group group_id="B1">
          <title>Arm A- Acala. 100 mg BID</title>
          <description>Arm A- Acalabrutinib 100 mg BID</description>
        </group>
        <group group_id="B2">
          <title>Arm B: Investigator Choice (IR or BR)-Main Study Period</title>
          <description>IR or BR data not presented separately similar to combined treatment arms approved for D8223C00009</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="155"/>
            <count group_id="B2" value="155"/>
            <count group_id="B3" value="310"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Age &lt; 65 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age &gt;=65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="97"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="195"/>
                  </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="47"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="102"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="108"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="208"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="147"/>
                    <measurement group_id="B2" value="129"/>
                    <measurement group_id="B3" value="276"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="145"/>
                    <measurement group_id="B2" value="141"/>
                    <measurement group_id="B3" value="286"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>North America</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>New Zealand</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Europe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="131"/>
                    <measurement group_id="B2" value="132"/>
                    <measurement group_id="B3" value="263"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Taiwan, Province Of China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hong Kong</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Korea, Republic Of</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Singapore</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Progression-free Survival (PFS) Per Independent Review Committee (IRC) Assessment</title>
        <description>To evaluate the efficacy of acalabrutinib monotherapy (Arm A) compared with idelalisib/rituximab or bendamustine/rituximab (Arm B) based on Independent Review Committee (IRC) assessment of progression-free survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria (Hallek 2008) with incorporation of the clarification for treatment-related lymphocytosis (Cheson 2012) hereafter referred to as IWCLL 2008 criteria in subjects with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). As planned and reported in the interim clinical study report (dated 17 July 2019), because the study did cross the boundary at interim analysis.&#xD;
IRC assessments were discontinued after the interim analysis. All IRC-related efficacy analyses in this clinical study report were based on the interim analysis data cutoff date of 15 January 2019. All other efficacy analyses were based on the final analysis data cutoff date of 03 September 2021.</description>
        <time_frame>IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up</time_frame>
        <population>Intent-to-treat population including all randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A: Acalabrutinib Monotherapy</title>
            <description>Acalabrutinib 100 mg orally twice a day</description>
          </group>
          <group group_id="O2">
            <title>Arm B: Investigators Choice</title>
            <description>Idelalisib+Rituximab or Bendamustine + Retuximab</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival (PFS) Per Independent Review Committee (IRC) Assessment</title>
          <description>To evaluate the efficacy of acalabrutinib monotherapy (Arm A) compared with idelalisib/rituximab or bendamustine/rituximab (Arm B) based on Independent Review Committee (IRC) assessment of progression-free survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria (Hallek 2008) with incorporation of the clarification for treatment-related lymphocytosis (Cheson 2012) hereafter referred to as IWCLL 2008 criteria in subjects with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). As planned and reported in the interim clinical study report (dated 17 July 2019), because the study did cross the boundary at interim analysis.&#xD;
IRC assessments were discontinued after the interim analysis. All IRC-related efficacy analyses in this clinical study report were based on the interim analysis data cutoff date of 15 January 2019. All other efficacy analyses were based on the final analysis data cutoff date of 03 September 2021.</description>
          <population>Intent-to-treat population including all randomized participants</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="155"/>
                <count group_id="O2" value="155"/>
              </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">Kaplan-Meier Estimated Median PFS and 95% were not reached for Arm A.</measurement>
                    <measurement group_id="O2" value="16.5" lower_limit="14.0" upper_limit="17.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Stratified by randomization stratification factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.20</ci_lower_limit>
            <ci_upper_limit>0.49</ci_upper_limit>
            <estimate_desc>Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-free Survival (PFS) Per Investigator Assessment</title>
        <description>PFS per investigator assessment based on the final analysis data cutoff date of 03 September 2021.</description>
        <time_frame>From randomization date to date of disease progression or death due to any cause or data cutoff date on 03Sep2021, whichever came first, regardless of use of subsequent anticancer therapy, until 53 months of follow-up.</time_frame>
        <population>Intent-to-treat population including all randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A: Acalabrutinib Monotherapy</title>
            <description>Acalabrutinib 100 mg orally twice a day</description>
          </group>
          <group group_id="O2">
            <title>Arm B: Investigator's Choice</title>
            <description>Idelalisib+Rituximab or Bendamustine + Retuximab</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival (PFS) Per Investigator Assessment</title>
          <description>PFS per investigator assessment based on the final analysis data cutoff date of 03 September 2021.</description>
          <population>Intent-to-treat population including all randomized participants</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="155"/>
                <count group_id="O2" value="155"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="45.8" upper_limit="NA">Kaplan-Meier Estimates for median PFS and upper 95% CI were not reached for Arm A.</measurement>
                    <measurement group_id="O2" value="16.8" lower_limit="14.1" upper_limit="22.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Stratified by randomization stratification factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.20</ci_lower_limit>
            <ci_upper_limit>0.38</ci_upper_limit>
            <estimate_desc>Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>IRC-assessed Overall Response Rate (ORR) Per IWCLL 2008 Criteria Based on Data Cutoff 15 January 2019 From Interim Analysis</title>
        <description>IRC-assessed overall response rate (ORR) including complete response (CR), CR with incomplete blood count recovery (CRi) nodular PR (nPR), and Partial Response (PR)</description>
        <time_frame>IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up</time_frame>
        <population>Intent-to-treat population including all randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A: Acalabrutinib Monotherapy</title>
            <description>Acalabrutinib 100 mg orally twice a day</description>
          </group>
          <group group_id="O2">
            <title>Arm B: Investigator's Choice</title>
            <description>Idelalisib+Rituximab or Bendamustine + Retuximab</description>
          </group>
        </group_list>
        <measure>
          <title>IRC-assessed Overall Response Rate (ORR) Per IWCLL 2008 Criteria Based on Data Cutoff 15 January 2019 From Interim Analysis</title>
          <description>IRC-assessed overall response rate (ORR) including complete response (CR), CR with incomplete blood count recovery (CRi) nodular PR (nPR), and Partial Response (PR)</description>
          <population>Intent-to-treat population including all randomized participants</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="155"/>
                <count group_id="O2" value="155"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126"/>
                    <measurement group_id="O2" value="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.2248</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.</method_desc>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>5.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.3</ci_lower_limit>
            <ci_upper_limit>14.9</ci_upper_limit>
            <estimate_desc>Risk difference (% Arm A - Arm B) based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Investigator Assessed Overall Response Rate (ORR) Per IWCLL 2008 Criteria Based on Data Cutoff 03 September 2021</title>
        <description>IRC-assessed overall response rate (ORR) including complete response (CR), CR with incomplete blood count recovery (CRi) nodular PR (nPR), and Partial Response (PR)</description>
        <time_frame>Investigator assessments were done from randomization date until date of death or date of exit from study or data cut off date on 03Sep2021, whichever came first, up to 53 months of follow-up.</time_frame>
        <population>Intent-to-treat population including all randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A: Acalabrutinib Monotherapy</title>
            <description>Acalabrutinib 100 mg orally twice a day</description>
          </group>
          <group group_id="O2">
            <title>Arm B: Investigator's Choice</title>
            <description>Idelalisib+Rituximab or Bendamustine + Retuximab</description>
          </group>
        </group_list>
        <measure>
          <title>Investigator Assessed Overall Response Rate (ORR) Per IWCLL 2008 Criteria Based on Data Cutoff 03 September 2021</title>
          <description>IRC-assessed overall response rate (ORR) including complete response (CR), CR with incomplete blood count recovery (CRi) nodular PR (nPR), and Partial Response (PR)</description>
          <population>Intent-to-treat population including all randomized participants</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="155"/>
                <count group_id="O2" value="155"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="128"/>
                    <measurement group_id="O2" value="130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.7340</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.</method_desc>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>-1.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.6</ci_lower_limit>
            <ci_upper_limit>7.0</ci_upper_limit>
            <estimate_desc>Risk difference (% Arm A - Arm B) based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>Overall Survival (OS) was based on data cutoff date of 03Sep2021</description>
        <time_frame>From randomization date to date of death due to any cause, or date of study discontinuation, or date of data cutoff on 03Sep2021, whichever came first until 54 months of follow-up.</time_frame>
        <population>Intent-to treat (ITT) population including all randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A: Acalabrutinib Monotherapy</title>
            <description>Acalabrutinib 100 mg orally twice a day</description>
          </group>
          <group group_id="O2">
            <title>Arm B: Investigator's Choice</title>
            <description>Idelalisib+Rituximab or Bendamustine + Retuximab</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>Overall Survival (OS) was based on data cutoff date of 03Sep2021</description>
          <population>Intent-to treat (ITT) population including all randomized participants</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="155"/>
                <count group_id="O2" value="155"/>
              </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">Kaplan-Meier estimate for median OS and 95% CIs were not reached.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Kaplan-Meier estimate for median OS and 95% CIs were not reached.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis stratified by factors recorded in IXRS data including presence of deletion 17 p (yes / no), ECOG (0-1/2), # of prior therapies (1-3/4+).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0783</p_value>
            <method>Log Rank</method>
            <method_desc>Log-Rank Analysis stratified by factors recorded in IXRS data: presence of deletion 17 p (yes / no), ECOG (0-1/2), # of prior therapies (1-3/4+).</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.69</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.46</ci_lower_limit>
            <ci_upper_limit>1.04</ci_upper_limit>
            <estimate_desc>Cox proportional hazard analysis stratified (Arm A vs. Arm B) by factors recorded in IXRS data including presence of deletion 17 p (yes / no), ECOG (0-1/2), # of prior therapies (1-3/4+).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DOR) Per Independent Review Committee (IRC) Assessment Based on 15 January 2019 Data Cutoff From Interim Analysis.</title>
        <description>Duration of Response (DOR) is defined as from the first documentation of CR, CRi, PR, or nPR to the earlier of the first documentation of disease progression or death from any cause.</description>
        <time_frame>IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up</time_frame>
        <population>Intent to treat (ITT) population including all randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A: Acalabrutinib Monotherapy</title>
            <description>Acalabrutinib 100 mg orally twice a day</description>
          </group>
          <group group_id="O2">
            <title>Arm B: Investigator's Choice</title>
            <description>Idelalisib+Rituximab or Bendamustine + Retuximab</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response (DOR) Per Independent Review Committee (IRC) Assessment Based on 15 January 2019 Data Cutoff From Interim Analysis.</title>
          <description>Duration of Response (DOR) is defined as from the first documentation of CR, CRi, PR, or nPR to the earlier of the first documentation of disease progression or death from any cause.</description>
          <population>Intent to treat (ITT) population including all randomized participants</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="155"/>
                <count group_id="O2" value="155"/>
              </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">Kaplan-Meier Estimate of median DOR and 95% CI were not reached.</measurement>
                    <measurement group_id="O2" value="13.6" lower_limit="11.9" upper_limit="NA">Kaplan-Meier estimate of upper 95% CI for median DOR was not reached.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Log Rank Test stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.19</ci_lower_limit>
            <ci_upper_limit>0.59</ci_upper_limit>
            <estimate_desc>Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DOR) Per Investigator Assessment Based on 03 September 2021 Data Cutoff</title>
        <description>Duration of Response (DOR) is defined as from the first documentation of CR, CRi, PR, or nPR to the earlier of the first documentation of disease progression or death from any cause.</description>
        <time_frame>Investigator assessments were done from randomization date until date of death or study discontinuation or data cutoff date on 03Sep2021, whichever came first up to 53 months of follow-up.</time_frame>
        <population>Intent to treat (ITT) population including all randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A: Acalabrutinib Monotherapy</title>
            <description>Acalabrutinib 100 mg orally twice a day</description>
          </group>
          <group group_id="O2">
            <title>Arm B: Investigator's Choice</title>
            <description>Idelalisib+Rituximab or Bendamustine + Retuximab</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response (DOR) Per Investigator Assessment Based on 03 September 2021 Data Cutoff</title>
          <description>Duration of Response (DOR) is defined as from the first documentation of CR, CRi, PR, or nPR to the earlier of the first documentation of disease progression or death from any cause.</description>
          <population>Intent to treat (ITT) population including all randomized participants</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="155"/>
                <count group_id="O2" value="155"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="41.5" upper_limit="NA">Kaplan-Meier estimate of median DOR and upper 95% CI were not reached.</measurement>
                    <measurement group_id="O2" value="18.3" lower_limit="11.9" upper_limit="21.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Log Rank Test stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.16</ci_lower_limit>
            <ci_upper_limit>0.33</ci_upper_limit>
            <estimate_desc>Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Next Treatment (TTNT) Based on 03 September 2021 Data Cutoff</title>
        <description>Time to Next Treatment (TTNT) is defined as the time from date of randomization to date of institution of non-protocol-specified treatment for CLL (or first dose date of acalabrutinib for Arm B subjects crossing over to receive acalabrutinib) or death due to any cause, whichever comes first.</description>
        <time_frame>From randomization date to start of non-protocol specified subsequent anticancer therapy for CLL or death due to any cause or study discontinuation or data cutoff date on 03Sep2021,, whichever came first up to 53 months of follow-up.</time_frame>
        <population>Intent to treat (ITT) population including all randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A: Acalabrutinib Monotherapy</title>
            <description>Acalabrutinib 100 mg orally twice a day</description>
          </group>
          <group group_id="O2">
            <title>Arm B: Investigator's Choice</title>
            <description>Idelalisib+Rituximab or Bendamustine + Retuximab</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Next Treatment (TTNT) Based on 03 September 2021 Data Cutoff</title>
          <description>Time to Next Treatment (TTNT) is defined as the time from date of randomization to date of institution of non-protocol-specified treatment for CLL (or first dose date of acalabrutinib for Arm B subjects crossing over to receive acalabrutinib) or death due to any cause, whichever comes first.</description>
          <population>Intent to treat (ITT) population including all randomized participants</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="155"/>
                <count group_id="O2" value="155"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="46.9" upper_limit="NA">Kaplan-Meier estimate of median TTNT and upper 95% CI were not reached.</measurement>
                    <measurement group_id="O2" value="22.5" lower_limit="17.5" upper_limit="25.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Log Rank Test stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.29</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.21</ci_lower_limit>
            <ci_upper_limit>0.40</ci_upper_limit>
            <estimate_desc>Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.</time_frame>
      <desc>Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.</desc>
      <group_list>
        <group group_id="E1">
          <title>Arm A- Acala. 100 mg BID</title>
          <description>Arm A- Acalabrutinib 100 mg BID</description>
        </group>
        <group group_id="E2">
          <title>Arm B: Investigator Choice (IR or BR)-Main Study Period</title>
          <description>IR or BR data not presented separately similar to combined treatment arms approved for D8223C00009</description>
        </group>
        <group group_id="E3">
          <title>Arm B Cross Over</title>
          <description>Arm B Investigator Choice Crossed Over to Acalabrutinib</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="155"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="155"/>
                <counts group_id="E3" subjects_affected="20" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="70" subjects_at_risk="154"/>
                <counts group_id="E2" subjects_affected="86" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="31" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Immune thrombocytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lymphocytosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="153"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Haemolytic anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cardiac failure chronic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cardiomyopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cardiopulmonary failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Incarcerated umbilical hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Intestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="22" subjects_affected="19" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Condition aggravated</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="154"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatitis toxic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Secondary immunodeficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Brain abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Bronchitis pneumococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Covid-19</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Covid-19 pneumonia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Epididymitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Escherichia sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Escherichia urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Haemophilus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Infective exacerbation of bronchiectasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Ophthalmic herpes zoster</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="154"/>
                <counts group_id="E2" events="14" subjects_affected="13" subjects_at_risk="153"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pneumonia fungal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pneumonia haemophilus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pneumonia klebsiella</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pneumonia legionella</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pneumonia pneumococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pneumonia pseudomonal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pseudomonal sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pseudomonas infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastroenteritis radiation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Cachexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Electrolyte imbalance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Tumour lysis syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Intervertebral disc compression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma gastric</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Brain neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Brain neoplasm malignant</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Laryngeal papilloma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Malignant melanoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Metastatic squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Nasopharyngeal cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Neuroendocrine carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pancreatic neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Tumour haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Altered state of consciousness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Aphasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cerebral ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Facial paresis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Ischaemic cerebral infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Laryngeal hypertrophy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Organising pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Skin disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Toxic skin eruption</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic aneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Circulatory collapse</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Iliac artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Peripheral venous disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 24.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="149" subjects_at_risk="154"/>
                <counts group_id="E2" subjects_affected="145" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="73" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperleukocytosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Immune thrombocytopenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Increased tendency to bruise</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="4" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lymph node pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lymphadenitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lymphocytosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="52" subjects_affected="27" subjects_at_risk="154"/>
                <counts group_id="E2" events="26" subjects_affected="17" subjects_at_risk="153"/>
                <counts group_id="E3" events="20" subjects_affected="16" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Monocytosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="75" subjects_affected="37" subjects_at_risk="154"/>
                <counts group_id="E2" events="202" subjects_affected="67" subjects_at_risk="153"/>
                <counts group_id="E3" events="16" subjects_affected="16" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Polycythaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Splenic infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="50" subjects_affected="20" subjects_at_risk="154"/>
                <counts group_id="E2" events="53" subjects_affected="24" subjects_at_risk="153"/>
                <counts group_id="E3" events="14" subjects_affected="11" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Anaemia of malignant disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Blood loss anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cytopenia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Granulocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="8" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypergammaglobulinaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="154"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cardiac failure chronic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Sinus arrhythmia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Supraventricular extrasystoles</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Ventricular extrasystoles</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Deafness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Deafness unilateral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Ear discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypoacusis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Presbyacusis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Accommodation disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="7" subjects_affected="4" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Conjunctival haemorrhage</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Eye irritation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Myopia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Orbital myositis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Visual acuity reduced</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastric mucosa erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastric polyps</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastric ulcer perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastrointestinal angiectasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastrointestinal inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastrointestinal toxicity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastrointestinal tract mucosal pigmentation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gingival bleeding</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gingival pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Glossodynia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Haemorrhoids thrombosed</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Immune-mediated enterocolitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lip haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lip pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Mouth cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="16" subjects_affected="13" subjects_at_risk="154"/>
                <counts group_id="E2" events="27" subjects_affected="24" subjects_at_risk="153"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Noninfective sialoadenitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Oesophageal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Oral mucosal blistering</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Oral mucosal eruption</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="154"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="154"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="153"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="154"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="153"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="154"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="153"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Anal fissure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Anal incontinence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Anorectal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Breath odour</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Chapped lips</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Chronic gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="15" subjects_affected="14" subjects_at_risk="154"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="45" subjects_affected="32" subjects_at_risk="154"/>
                <counts group_id="E2" events="128" subjects_affected="64" subjects_at_risk="153"/>
                <counts group_id="E3" events="12" subjects_affected="10" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Diverticulum intestinal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Duodenitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Duodenogastric reflux</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dysbiosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="154"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Enlarged uvula</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Faeces soft</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Fistula of small intestine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastric disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="13" subjects_affected="10" subjects_at_risk="154"/>
                <counts group_id="E2" events="13" subjects_affected="10" subjects_at_risk="153"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="154"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Device related thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Extravasation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="21" subjects_affected="19" subjects_at_risk="154"/>
                <counts group_id="E2" events="18" subjects_affected="18" subjects_at_risk="153"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Feeling cold</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hyperpyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hyperthermia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="9" subjects_affected="5" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Infusion site extravasation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="154"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="153"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="33" subjects_affected="25" subjects_at_risk="154"/>
                <counts group_id="E2" events="51" subjects_affected="29" subjects_at_risk="153"/>
                <counts group_id="E3" events="13" subjects_affected="10" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Secretion discharge</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Swelling face</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Systemic inflammatory response syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Biliary colic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cholestasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hepatic cytolysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hepatitis toxic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hepatotoxicity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypertransaminasaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Liver injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Contrast media allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Contrast media reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypogammaglobulinaemia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="7" subjects_at_risk="154"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Immunodeficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Secondary immunodeficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="4" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Aspergillus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Bacteriuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="30" subjects_affected="19" subjects_at_risk="154"/>
                <counts group_id="E2" events="14" subjects_affected="12" subjects_at_risk="153"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Bronchitis pneumococcal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Bronchopulmonary aspergillosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Covid-19</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="154"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="153"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Covid-19 pneumonia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Campylobacter gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Chronic sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus infection reactivation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus viraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Encephalitis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Epididymitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Epstein-barr virus infection reactivation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Escherichia urinary tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Eye infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Eye infection bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Fungal skin infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Furuncle</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastrointestinal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Haemophilus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hepatitis b</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hepatitis b reactivation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hepatitis c</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hepatitis e</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Herpes dermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Herpes simplex</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Herpes virus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="154"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Herpes zoster reactivation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Impetigo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Infected dermal cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Infective exacerbation of bronchiectasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="154"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Joint abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Nasal herpes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="23" subjects_affected="13" subjects_at_risk="154"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="153"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Oral fungal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Otitis externa</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pharyngitis bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="30" subjects_affected="30" subjects_at_risk="154"/>
                <counts group_id="E2" events="19" subjects_affected="19" subjects_at_risk="153"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pneumonia fungal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pneumonia pneumococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pseudomonal sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rash pustular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="27" subjects_affected="18" subjects_at_risk="154"/>
                <counts group_id="E2" events="15" subjects_affected="8" subjects_at_risk="153"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="12" subjects_affected="10" subjects_at_risk="154"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="12" subjects_affected="7" subjects_at_risk="154"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Sinusitis bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Skin bacterial infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Staphylococcal skin infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Tinea pedis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Tracheobronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="42" subjects_affected="31" subjects_at_risk="154"/>
                <counts group_id="E2" events="31" subjects_affected="24" subjects_at_risk="153"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="154"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Urinary tract infection enterococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Urinary tract infection pseudomonal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Wound infection pseudomonas</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Clavicle fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="23" subjects_affected="13" subjects_at_risk="154"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="153"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Eyelid contusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Facial bones fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Forearm fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastrointestinal procedural complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="29" subjects_affected="17" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Mouth injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Palate injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Periorbital haematoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Procedural complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Procedural nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Scratch</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Skin laceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="6" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Soft tissue injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Subcutaneous haematoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Vaccination complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="19" subjects_affected="4" subjects_at_risk="154"/>
                <counts group_id="E2" events="30" subjects_affected="17" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="23" subjects_affected="4" subjects_at_risk="154"/>
                <counts group_id="E2" events="21" subjects_affected="13" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Blood cholesterol increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="154"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="153"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Blood immunoglobulin g decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Blood iron decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Blood potassium decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Blood urea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Blood urea increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Blood uric acid increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Borrelia test positive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Breath sounds abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Candida test positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cardiac murmur</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Electrocardiogram qt prolonged</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Electrocardiogram repolarisation abnormality</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Faecal calprotectin increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="5" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="5" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hepatitis b dna assay positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Human rhinovirus test positive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Immunoglobulins decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Intraocular pressure increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lymphocyte count increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="154"/>
                <counts group_id="E2" events="23" subjects_affected="10" subjects_at_risk="153"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="12" subjects_affected="5" subjects_at_risk="154"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Sars-cov-2 test positive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Serum ferritin decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Streptococcus test positive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="18" subjects_affected="9" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="154"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="153"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal loss of weight</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cachexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Carbohydrate intolerance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="154"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="153"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dyslipidaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Fluid retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hyperhomocysteinaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="154"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Iron deficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Iron overload</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Steroid diabetes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Vitamin d deficiency</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Vitamin k deficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="24" subjects_affected="20" subjects_at_risk="154"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="153"/>
                <counts group_id="E3" events="14" subjects_affected="14" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="15" subjects_affected="12" subjects_at_risk="154"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="153"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Exostosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Haemarthrosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Intervertebral disc disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Joint effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Joint range of motion decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="154"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Osteoporosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="11" subjects_affected="8" subjects_at_risk="154"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pain in jaw</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Soft tissue swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Synovial cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Tenosynovitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenoma benign</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Anogenital warts</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Bladder transitional cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Bowen's disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Chronic lymphocytic leukaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Epstein barr virus positive mucocutaneous ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Haemangioma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Joint neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Laryngeal papilloma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lip squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lipoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Melanocytic naevus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Meningioma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Metastatic squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Neoplasm skin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Neurofibroma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rectal adenoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Seborrhoeic keratosis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Skin papilloma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" events="14" subjects_affected="10" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Ataxia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Balance disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Carotid artery thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cerebral small vessel ischaemic disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cognitive disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="17" subjects_affected="10" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dizziness postural</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dysaesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Facial paresis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="44" subjects_affected="36" subjects_at_risk="154"/>
                <counts group_id="E2" events="9" subjects_affected="7" subjects_at_risk="153"/>
                <counts group_id="E3" events="14" subjects_affected="12" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Memory impairment</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Muscle contractions involuntary</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Post herpetic neuralgia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Radiculopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Vertebral artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Vertebrobasilar insufficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Affective disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Eating disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="12" subjects_affected="9" subjects_at_risk="154"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="153"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Neurosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Stress</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Bladder dilatation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Bladder pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Polyuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Renal cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="154"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Renal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Erectile dysfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gynaecomastia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Heavy menstrual bleeding</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Prostatism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Prostatomegaly</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Spermatocele</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Vaginal haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Vulval oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Vulvar dysplasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Aphonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Bronchitis chronic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="37" subjects_affected="27" subjects_at_risk="154"/>
                <counts group_id="E2" events="29" subjects_affected="20" subjects_at_risk="153"/>
                <counts group_id="E3" events="10" subjects_affected="8" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dry throat</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="11" subjects_affected="8" subjects_at_risk="154"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="153"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="8" subjects_affected="5" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Laryngeal haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Laryngeal oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lung consolidation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lung disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lung infiltration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Nasal polyps</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Nasal septum perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Obstructive airways disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Organising pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="154"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Paranasal cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Paranasal sinus inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="154"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pulmonary congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pulmonary fibrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pulmonary mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Respiratory disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Sleep apnoea syndrome</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Tonsillar haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Upper-airway cough syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Actinic keratosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Decubitus ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dermatitis acneiform</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dermatitis bullous</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Eczema asteatotic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="8" subjects_affected="4" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hyperkeratosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lichen planus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lichenoid keratosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Nail disorder</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Onychoclasis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pain of skin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pemphigus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Petechiae</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Precancerous skin lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="154"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Purpura</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="18" subjects_affected="15" subjects_at_risk="154"/>
                <counts group_id="E2" events="33" subjects_affected="19" subjects_at_risk="153"/>
                <counts group_id="E3" events="7" subjects_affected="5" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rash erythematous</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rash macular</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="154"/>
                <counts group_id="E2" events="6" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rash papular</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rosacea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Seborrhoeic dermatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Skin disorder</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Skin exfoliation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Skin haemorrhage</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="154"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Skin ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Toxic skin eruption</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Arterial haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Capillary fragility</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="154"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="153"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="14" subjects_affected="11" subjects_at_risk="154"/>
                <counts group_id="E2" events="9" subjects_affected="7" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="153"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Peripheral artery occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Peripheral artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Peripheral vascular disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Peripheral venous disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Phlebitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Phlebitis superficial</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Poor peripheral circulation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis superficial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Varicose vein</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Vasculitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="154"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Venous thrombosis limb</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="154"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </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>Institution/Investigator will not publish or publicly present any study results without prior approval or prior to 12 months following completion of the study.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Astrazeneca Clinical Trial</organization>
      <phone>1-888-292-9613</phone>
      <email>information.center@astrazeneca.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/NCT02970318
org study id: ACE-CL-309
secondary id: 2015-004454-17
nct id: NCT02970318
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study is designed to evaluate the efficacy of acalabrutinib compared with rituximab in
      combination with idelalisib or bendamustine in previously treated subjects with chronic
      lymphocytic leukemia (CLL).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Progression-free Survival (PFS) Per Independent Review Committee (IRC) Assessment
time frame: IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up
description: To evaluate the efficacy of acalabrutinib monotherapy (Arm A) compared with idelalisib/rituximab or bendamustine/rituximab (Arm B) based on Independent Review Committee (IRC) assessment of progression-free survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria (Hallek 2008) with incorporation of the clarification for treatment-related lymphocytosis (Cheson 2012) hereafter referred to as IWCLL 2008 criteria in subjects with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). As planned and reported in the interim clinical study report (dated 17 July 2019), because the study did cross the boundary at interim analysis.
IRC assessments were discontinued after the interim analysis. All IRC-related efficacy analyses in this clinical study report were based on the interim analysis data cutoff date of 15 January 2019. All other efficacy analyses were based on the final analysis data cutoff date of 03 September 2021.
measure: Progression-free Survival (PFS) Per Investigator Assessment
time frame: From randomization date to date of disease progression or death due to any cause or data cutoff date on 03Sep2021, whichever came first, regardless of use of subsequent anticancer therapy, until 53 months of follow-up.
description: PFS per investigator assessment based on the final analysis data cutoff date of 03 September 2021.
measure: IRC-assessed Overall Response Rate (ORR) Per IWCLL 2008 Criteria Based on Data Cutoff 15 January 2019 From Interim Analysis
time frame: IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up
description: IRC-assessed overall response rate (ORR) including complete response (CR), CR with incomplete blood count recovery (CRi) nodular PR (nPR), and Partial Response (PR)
measure: Investigator Assessed Overall Response Rate (ORR) Per IWCLL 2008 Criteria Based on Data Cutoff 03 September 2021
time frame: Investigator assessments were done from randomization date until date of death or date of exit from study or data cut off date on 03Sep2021, whichever came first, up to 53 months of follow-up.
description: IRC-assessed overall response rate (ORR) including complete response (CR), CR with incomplete blood count recovery (CRi) nodular PR (nPR), and Partial Response (PR)
measure: Overall Survival (OS)
time frame: From randomization date to date of death due to any cause, or date of study discontinuation, or date of data cutoff on 03Sep2021, whichever came first until 54 months of follow-up.
description: Overall Survival (OS) was based on data cutoff date of 03Sep2021
measure: Duration of Response (DOR) Per Independent Review Committee (IRC) Assessment Based on 15 January 2019 Data Cutoff From Interim Analysis.
time frame: IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up
description: Duration of Response (DOR) is defined as from the first documentation of CR, CRi, PR, or nPR to the earlier of the first documentation of disease progression or death from any cause.
measure: Duration of Response (DOR) Per Investigator Assessment Based on 03 September 2021 Data Cutoff
time frame: Investigator assessments were done from randomization date until date of death or study discontinuation or data cutoff date on 03Sep2021, whichever came first up to 53 months of follow-up.
description: Duration of Response (DOR) is defined as from the first documentation of CR, CRi, PR, or nPR to the earlier of the first documentation of disease progression or death from any cause.
measure: Time to Next Treatment (TTNT) Based on 03 September 2021 Data Cutoff
time frame: From randomization date to start of non-protocol specified subsequent anticancer therapy for CLL or death due to any cause or study discontinuation or data cutoff date on 03Sep2021,, whichever came first up to 53 months of follow-up.
description: Time to Next Treatment (TTNT) is defined as the time from date of randomization to date of institution of non-protocol-specified treatment for CLL (or first dose date of acalabrutinib for Arm B subjects crossing over to receive acalabrutinib) or death due to any cause, whichever comes first.
arm group label: Acalabrutinib (ACP-196)
arm group type: Experimental
description: Acalabrutinib (ACP-196) Monotherapy
arm group label: Rituximab Plus Idelalisib or Bendamustine
arm group type: Active Comparator
description: Investigator's Choice of Rituximab Plus Idelalisib or Bendamustine
intervention type: Drug
intervention name: Acalabrutinib (ACP-196)
description: Acalabrutinib monotherapy
arm group label: Acalabrutinib (ACP-196)
intervention type: Drug
intervention name: Rituximab
description: Rituximab in combination with idelalisib or bendamustine
arm group label: Rituximab Plus Idelalisib or Bendamustine
intervention type: Drug
intervention name: Idelalisib
description: Idelalisib in combination with rituximab
arm group label: Rituximab Plus Idelalisib or Bendamustine
intervention type: Drug
intervention name: Bendamustine
description: Bendamustine in combination with rituximab
arm group label: Rituximab Plus Idelalisib or Bendamustine
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Acerta Clinical Trials
role: Study Director
affiliation: 1-888-292-9613; acertamc@dlss.com
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country: Australia
country: Austria
country: Belgium
country: Bulgaria
country: Canada
country: Croatia
country: Czechia
country: France
country: Germany
country: Hong Kong
country: Hungary
country: Israel
country: Italy
country: Korea, Republic of
country: New Zealand
country: Poland
country: Russian Federation
country: Singapore
country: Slovakia
country: Spain
country: Sweden
country: Taiwan
country: Ukraine
country: United Kingdom
country: United States
country: Turkey
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=ACE-CL-309&amp;attachmentIdentifier=4d2fac79-d899-4138-8657-0bb2b540784b&amp;fileName=ace-cl-309-csp-amend-8-redact.pdf&amp;versionIdentifier=
description: Redacted CSP
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=ACE-CL-309&amp;attachmentIdentifier=5ba8b7a4-ac40-4f7a-b333-9c025218e080&amp;fileName=ace-cl-309-sap-ed-3-redact.pdf&amp;versionIdentifier=
description: Redacted SAP
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=ACE-CL-309&amp;attachmentIdentifier=aa63aaa7-e136-4da4-89c9-2ad21beb4457&amp;fileName=ace-cl-309-Study_Synopsis-redact.pdf&amp;versionIdentifier=
description: Redacted CSR synopsis
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Lymphoid
mesh term: Leukemia, Lymphocytic, Chronic, B-Cell
mesh term: Rituximab
mesh term: Bendamustine Hydrochloride
mesh term: Acalabrutinib
mesh term: Idelalisib
sharing ipd: Yes
ipd description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd access criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd url: https://astrazenecagroup-dt.pharmacm.com/DT/Home
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 