<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/NCT02993523</url>
  </required_header>
  <id_info>
    <org_study_id>M15-656</org_study_id>
    <secondary_id>2016-001466-28</secondary_id>
    <nct_id>NCT02993523</nct_id>
  </id_info>
  <brief_title>A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Participants With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy</brief_title>
  <acronym>Viale-a</acronym>
  <official_title>A Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Subjects With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Genentech, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>AbbVie</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute Myeloid Leukaemia (AML) is an aggressive and rare cancer of myeloid cells (a white&#xD;
      blood cell responsible for fighting infections). Successful treatment of AML is dependent on&#xD;
      what subtype of AML the participant has, and the age of the participant when diagnosed.&#xD;
&#xD;
      Venetoclax is an experimental drug that kills cancer cells by blocking a protein (part of a&#xD;
      cell) that allows cancer cells to stay alive. This study is designed to see if adding&#xD;
      venetoclax to azacitidine works better than azacitidine on its own.&#xD;
&#xD;
      This is a Phase 3, randomized, double-blind (treatment is unknown to participants and&#xD;
      doctors), placebo controlled study in patients with AML who are &gt;= 18 or more years old and&#xD;
      have not been treated before. Participants who take part in this study should not be suitable&#xD;
      for standard induction therapy (usual starting treatment). AbbVie is funding this study which&#xD;
      will take place at approximately 180 hospitals globally and enroll approximately 400&#xD;
      participants.&#xD;
&#xD;
      In this study, 2/3 of participants will receive venetoclax every day with azacitidine and the&#xD;
      remaining 1/3 will receive placebo (dummy) tablets with azacitidine.&#xD;
&#xD;
      Participants will continue to have study visits and receive treatment for as long as they are&#xD;
      having a clinical benefit. The effect of the treatment on AML will be checked by taking&#xD;
      blood, bone marrow, scans, measuring side effects and by completing health questionnaires.&#xD;
      Blood and bone marrow tests will be completed to see why some people respond better than&#xD;
      others. Additional blood tests will be completed for genetic factors and to see how long the&#xD;
      drug remains in the body.&#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 25, 2024</completion_date>
  <primary_completion_date type="Actual">December 1, 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>Yes</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>From the study start up to death or alive or lost to follow-up (up to approximately 4.8 years; data cut off date: 1 December 2021)</time_frame>
    <description>OS is defined as the number of days from the date of randomization to the date of death. Log rank test was used to compare the OS distribution between two treatment arms. Cox regression was used to report the hazard ratio.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Marrow Recovery (CRi)</measure>
    <time_frame>From the study start up to death (up to approximately 4.8 years; data cut-off date: 1 December 2021)</time_frame>
    <description>CR and CRi was calculated based on current International Working Group (IWG) criteria. CR is defined as absolute neutrophil count &gt;10^3/ microliter (mcL), platelets &gt;10^5/mcL, red cell transfusion independence, and bone marrow with &lt;5% blasts. CRi is defined as bone marrow with less than 5% blasts, and absolute neutrophils of ≤10^3/mcL or platelets ≤10^5/mcL. Percentages are rounded off to whole number at the nearest decimal.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Event-free Survival (EFS)</measure>
    <time_frame>Measured up to 2 years after the last participant is randomized</time_frame>
    <description>EFS will be defined as the number of days from randomization to the date of progressive disease, relapse from CR or CRi, treatment failure or death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Health Status/Quality of Life (GHS/QoL)</measure>
    <time_frame>Measured at participant's Day 1 of Cycle 1 (each cycle is 28 days) and at Day 1 of every Cycle thereafter for up to 2 years following the last subject last visit</time_frame>
    <description>Improvement in GHS/QoL will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Composite Complete Remission (CR or CRi)</measure>
    <time_frame>Up to 6 months after the first 225 participants are randomized</time_frame>
    <description>This will be calculated based on current International Working Group (IWG) criteria. CR is defined as absolute neutrophil count &gt; 10^3/mcL, platelets &gt; 10^5/mcL, red cell transfusion independence, and bone marrow with &lt; 5% blasts. CRi is defined as bone marrow with less than 5% blasts, and absolute neutrophils of &lt;= 10^3/mcL or platelets &lt;= 10^5/mcL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Remission or Complete Remission With Partial Hematologic Recovery Rate (CR+CRh)</measure>
    <time_frame>Measured up to 2 years after the last participant is randomized</time_frame>
    <description>A response of CRh is defined as Bone marrow with &lt;5% blasts, peripheral blood neutrophil count &gt;0.5*10^3/mcL and peripheral blood platelet count &gt;0.5*10^5/mcL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post Baseline Transfusion Independence Rate</measure>
    <time_frame>Measured up to 2 years after the last participant is randomized</time_frame>
    <description>Transfusion Independence is defined as a period of 56 days with no transfusion between first dose of study drug and the last dose of study drug + 30 days. The rate of conversion for red blood cells (RBC) and platelets is defined as percentage of participants being post-baseline transfusion independent from baseline transfusion dependence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Remission (CR) Rate</measure>
    <time_frame>Measured up to 2 years after the last participant is randomized</time_frame>
    <description>The percentage of participants with complete remission (CR) will be calculated based on the modified IWG criteria for AML.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue/Quality of Life (QoL)</measure>
    <time_frame>Measured at participant's Day 1 of Cycle 1 (each cycle is 28 days) and at Day 1 of every Cycle thereafter for up to 2 years following the last participant last visit</time_frame>
    <description>Fatigue QoL will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Fatigue Short Form (SF) 7a global fatigue score</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">443</enrollment>
  <condition>Acute Myeloid Leukemia (AML)</condition>
  <arm_group>
    <arm_group_label>Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants enrolled under original protocol and enrolled during or after protocol amendment 1 received venetoclax-matching placebo, orally, every day (QD), from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, subcutaneously (SC) or intravenously (IV), QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 1 and Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants enrolled under original protocol and enrolled during or after protocol amendment 1 received venetoclax 100 mg, once orally, on Day 1 of Cycle 1 followed by venetoclax 200 mg, once orally, on Day 2 of Cycle 1 and venetoclax 400 mg, orally, QD, on Day 3 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants received venetoclax 400 mg, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azacitidine</intervention_name>
    <description>Solution for subcutaneous or intravenous administration.</description>
    <arm_group_label>Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2</arm_group_label>
    <arm_group_label>Group 1 and Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2</arm_group_label>
    <arm_group_label>Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Venetoclax</intervention_name>
    <description>Tablet</description>
    <arm_group_label>Group 1 and Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2</arm_group_label>
    <arm_group_label>Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2</arm_group_label>
    <other_name>ABT-199</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching placebo tablet</description>
    <arm_group_label>Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant must have confirmation of Acute Myeloid Leukemia (AML) by World Health&#xD;
             Organization (WHO) criteria, previously untreated and be ineligible for treatment with&#xD;
             a standard cytarabine and anthracycline induction regimen due age or comorbidities.&#xD;
&#xD;
          -  Participant must be &gt;= 18 years of age.&#xD;
&#xD;
          -  Participant must have a projected life expectancy of at least 12 weeks.&#xD;
&#xD;
          -  Participant must be considered ineligible for induction therapy defined by the&#xD;
             following:&#xD;
&#xD;
             a. &gt;= 75 years of age; or b. &gt;= 18 to 74 years of age with at least one of the&#xD;
             following comorbidities: i. Eastern Cooperative Oncology Group (ECOG) Performance&#xD;
             Status of 2 or 3; ii. Cardiac history of Congestive Heart Failure (CHF) requiring&#xD;
             treatment or Ejection Fraction &lt;= 50% or chronic stable angina; iii. Diffusing&#xD;
             capacity of the Lung for Carbon Monoxide (DLCO) &lt;= 65% or Forced Expiratory Volume in&#xD;
             1 second (FEV1) &lt;= 65%; iv. Creatinine clearance &gt;= 30 mL/min to &lt; 45 ml/min; v.&#xD;
             Moderate hepatic impairment with total bilirubin &gt; 1.5 to &lt;= 3.0 × Upper Limit of&#xD;
             Normal (ULN); vi. Any other comorbidity that the physician judges to be incompatible&#xD;
             with intensive chemotherapy must be reviewed and approved by the AbbVie Therapeutic&#xD;
             Medical Director during screening and before study enrollment.&#xD;
&#xD;
          -  Participant must have an ECOG Performance status:&#xD;
&#xD;
               1. 0 to 2 for Participants &gt;= 75 years of age or&#xD;
&#xD;
               2. 0 to 3 for Participants &gt;= 18 to 74 years of age.&#xD;
&#xD;
          -  Participant must have adequate renal function as demonstrated by a creatinine &gt;= 30&#xD;
             mL/min; calculated by the Cockcroft Gault formula or measured by 24 hours urine&#xD;
             collection.&#xD;
&#xD;
          -  Participant must have adequate liver function as demonstrated by:&#xD;
&#xD;
               1. aspartate aminotransferase (AST) &lt;= 3.0 x ULN*&#xD;
&#xD;
               2. alanine aminotransferase (ALT) &lt;= 3.0 x ULN*&#xD;
&#xD;
               3. bilirubin &lt;= 1.5 x ULN* * Unless considered to be due to leukemic organ&#xD;
                  involvement&#xD;
&#xD;
             i. Participants who are &lt; 75 years of age may have a bilirubin of &lt;= 3.0 x ULN&#xD;
&#xD;
          -  Female participants must be either postmenopausal defined as:&#xD;
&#xD;
               1. Age &gt; 55 years with no menses for 12 or more months without an alternative&#xD;
                  medical cause.&#xD;
&#xD;
               2. Age ≤ 55 years with no menses for 12 or more months without an alternative&#xD;
                  medical cause AND an follicle stimulating hormone (FSH) level &gt;40 international&#xD;
                  units per liter (IU/L); or&#xD;
&#xD;
               3. Permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or&#xD;
                  hysterectomy); or&#xD;
&#xD;
               4. Women of Childbearing Potential (WOCBP) practicing at least one protocol&#xD;
                  specified method of birth control, starting at Study Day 1 through at least 90&#xD;
                  days after the last dose of study drug.&#xD;
&#xD;
          -  Male participants who are sexually active, must agree, from Study Day 1 through at&#xD;
             least 90 days after the last dose of study drug, to practice the protocol specified&#xD;
             contraception. Male subjects must agree to refrain from sperm donation from initial&#xD;
             study drug administration through at least 90 days after the last dose of study drug.&#xD;
&#xD;
          -  Female participants of childbearing potential must have negative results for pregnancy&#xD;
             test performed:&#xD;
&#xD;
               1. At Screening with a serum sample obtained within 14 days prior to the first study&#xD;
                  drug administration, and&#xD;
&#xD;
               2. Prior to dosing with urine sample obtained on Cycle 1 Day 1, if it has been &gt; 7&#xD;
                  days since obtaining the serum pregnancy test results.&#xD;
&#xD;
          -  Participant must voluntarily sign and date an informed consent, approved by an&#xD;
             Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the&#xD;
             initiation of any screening or study-specific procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant has received treatment with the following:&#xD;
&#xD;
               1. A hypomethylating agent, venetoclax and/or chemo therapeutic agent for&#xD;
                  Myelodysplastic syndrome (MDS).&#xD;
&#xD;
               2. Chimeric Antigen Receptor (CAR)-T cell therapy.&#xD;
&#xD;
               3. Experimental therapies for MDS or Acute Myeloid Leukemia (AML).&#xD;
&#xD;
               4. Current participation in another research or observational study.&#xD;
&#xD;
          -  Participant has history of myeloproliferative neoplasm (MPN) including myelofibrosis,&#xD;
             essential thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or&#xD;
             without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.&#xD;
&#xD;
          -  Participant has the following:&#xD;
&#xD;
             a. Favorable risk cytogenetics such as t(8;21), inv(16) or t(16;16) or t(15;17) as per&#xD;
             the National Comprehensive Cancer Network (NCCN) Guidelines Version 2, 2016 for Acute&#xD;
             Myeloid Leukemia.&#xD;
&#xD;
          -  Participant has acute promyelocytic leukemia&#xD;
&#xD;
          -  Participant has known active central nervous system (CNS) involvement with AML.&#xD;
&#xD;
          -  Participant has known human immunodeficiency virus (HIV) infection (due to potential&#xD;
             drug-drug interactions between antiretroviral medications and venetoclax) HIV testing&#xD;
             will be performed at Screening, only if required per local guidelines or institutional&#xD;
             standards.&#xD;
&#xD;
          -  Participant is known to be positive for hepatitis B or C infection [HCV Ab indicative&#xD;
             of a previous or current infection; and/or positive HBs Ag or detected sensitivity on&#xD;
             hepatitis B virus (HBV) deoxyribonucleic acid (DNA) polymerase chain reaction (PCR)&#xD;
             test for HBc Ab and/or HBs Ab positivity] with the exception of those with an&#xD;
             undetectable viral load within 3 months screening. Hepatitis B or C testing is not&#xD;
             required.&#xD;
&#xD;
          -  Participant has received strong and/or moderate CYP3A inducers within 7 days prior to&#xD;
             the initiation of study treatment; additional details as described in the protocol.&#xD;
&#xD;
          -  Participant has consumed grapefruit, grapefruit products, Seville oranges (including&#xD;
             marmalade containing Seville oranges) or Starfruit within 3 days prior to the&#xD;
             initiation of study treatment.&#xD;
&#xD;
          -  Participant has a cardiovascular disability status of New York Heart Association Class&#xD;
             &gt; 2. Class 2 is defined as cardiac disease in which patients are comfortable at rest&#xD;
             but ordinary physical activity results in fatigue, palpitations, dyspnea, or anginal&#xD;
             pain.&#xD;
&#xD;
          -  Participant has chronic respiratory disease that requires continuous oxygen, or&#xD;
             significant history of renal, neurologic, psychiatric, endocrinologic, metabolic,&#xD;
             immunologic, hepatic, cardiovascular disease, any other medical condition or known&#xD;
             hypersensitivity to any of the study medications including excipients of azacitidine&#xD;
             that in the opinion of the investigator would adversely affect his/her participating&#xD;
             in this study.&#xD;
&#xD;
          -  Participant has a malabsorption syndrome or other condition that precludes enteral&#xD;
             route of administration.&#xD;
&#xD;
          -  Participant exhibits evidence of other clinically significant uncontrolled systemic&#xD;
             infection requiring therapy (viral, bacterial or fungal).&#xD;
&#xD;
          -  Participant has a history of other malignancies within 2 years prior to study entry,&#xD;
             with the exception of:&#xD;
&#xD;
               1. Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of&#xD;
                  breast;&#xD;
&#xD;
               2. Basal cell carcinoma of the skin or localized squamous cell carcinoma of the&#xD;
                  skin;&#xD;
&#xD;
               3. Previous malignancy confined and surgically resected (or treated with other&#xD;
                  modalities) with curative intent; requires discussion with TA MD.&#xD;
&#xD;
          -  Participant has a white blood cell count &gt; 25 × 10^9/L. (Hydroxyurea or leukapheresis&#xD;
             are permitted to meet this criterion.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ABBVIE INC.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City of Hope /ID# 154105</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, Los Angeles /ID# 154107</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, Davis Comprehensive Cancer Center /ID# 162725</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory Midtown Infectious Disease Clinic /ID# 162534</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University Feinberg School of Medicine /ID# 201133</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611-2927</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago Medicine /ID# 154108</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637-1426</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fort Wayne Medical Oncology /ID# 157190</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cotton-O'Neil Clinical Res Ctr /ID# 155136</name>
      <address>
        <city>Topeka</city>
        <state>Kansas</state>
        <zip>66606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norton Cancer Institute /ID# 154992</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202-3700</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EMMC Cancer Care /ID# 154991</name>
      <address>
        <city>Brewer</city>
        <state>Maine</state>
        <zip>04412</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University /ID# 154104</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital /ID# 200752</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center /ID# 201155</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215-5400</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute /ID# 167009</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sepctrum Health Medical Center /ID# 159522</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia Univ Medical Center /ID# 154101</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032-3725</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center-Koch Center /ID# 165077</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065-6007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke Cancer Center /ID# 154106</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710-3000</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh MC /ID# 154102</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology-Nashville Centennial /ID# 200854</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203-1632</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center /ID# 154100</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Scott &amp; White Medical Center- Temple /ID# 157191</name>
      <address>
        <city>Temple</city>
        <state>Texas</state>
        <zip>76508-0001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah /ID# 157192</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112-5500</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Of Vermont Medical /ID# 157196</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Alexandra Hospital /ID# 154272</name>
      <address>
        <city>Woolloongabba</city>
        <state>Queensland</state>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital /ID# 154271</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alfred Health /ID# 154275</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincent's Hospital Melbourne /ID# 155094</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Melbourne Hospital /ID# 155095</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Charles Gairdner Hospital /ID# 163924</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Perth Hospital /ID# 154274</name>
      <address>
        <city>Perth</city>
        <state>Western Australia</state>
        <zip>6000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum St. Poelten /ID# 167436</name>
      <address>
        <city>Sankt Poelten</city>
        <state>Niederoesterreich</state>
        <zip>3100</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 154888</name>
      <address>
        <city>Linz</city>
        <state>Oberoesterreich</state>
        <zip>4010</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordensklinikum Linz GmbH Elisabethinen /ID# 154885</name>
      <address>
        <city>Linz</city>
        <state>Oberoesterreich</state>
        <zip>4010</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universitaet Graz /ID# 157882</name>
      <address>
        <city>Graz</city>
        <state>Steiermark</state>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duplicate_Landeskrankenhaus Salzburg /ID# 169719</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hanusch Krankenhaus /ID# 155676</name>
      <address>
        <city>Wien</city>
        <zip>1140</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Brussel /ID# 153393</name>
      <address>
        <city>Jette</city>
        <state>Bruxelles-Capitale</state>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCL Saint-Luc /ID# 153391</name>
      <address>
        <city>Woluwe-Saint-Lambert</city>
        <state>Bruxelles-Capitale</state>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gent /ID# 153392</name>
      <address>
        <city>Gent</city>
        <state>Oost-Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Sint-Jan Brugge /ID# 154041</name>
      <address>
        <city>Brugge</city>
        <zip>8000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Clinicas de Porto Alegre /ID# 157779</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 153099</name>
      <address>
        <city>Ribeirão Preto</city>
        <state>Sao Paulo</state>
        <zip>14051-140</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Ensino e Pesquisa São Lucas /ID# 157778</name>
      <address>
        <city>São Paulo</city>
        <state>Sao Paulo</state>
        <zip>01236-030</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto do Câncer do Estado de São Paulo - ICESP /ID# 153095</name>
      <address>
        <city>São Paulo</city>
        <state>Sao Paulo</state>
        <zip>01246-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tom Baker Cancer Centre /ID# 159645</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Paul's Hospital /ID# 159644</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6Z 1Y6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juravinski Cancer Centre /ID# 153650</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V 1C3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ottawa Hospital Research Institute /ID# 153541</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre /ID# 153651</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fujian Medical University Union Hospital /ID# 167314</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanfang Hospital of Southern Medical University /ID# 170148</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510515</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Hebei Medical University /ID# 167316</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Cancer Hospital /ID# 167320</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 167315</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167493</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Hospital /ID# 167489</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Jilin University /ID# 167490</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 167318</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200065</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital, Sichuan University /ID# 167492</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Hematology &amp; Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 167487</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300020</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 167317</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qilu Hospital of Shandong University /ID# 167485</name>
      <address>
        <city>Jinan</city>
        <zip>250012</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Hospital Dubrava /ID# 153515</name>
      <address>
        <city>Zagreb</city>
        <state>Grad Zagreb</state>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinicki bolnicki centar Zagreb /ID# 153383</name>
      <address>
        <city>Zagreb</city>
        <state>Grad Zagreb</state>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duplicate_Klinicki bolnicki centar Osijek /ID# 153623</name>
      <address>
        <city>Osijek</city>
        <state>Osjecko-baranjska Zupanija</state>
        <zip>31000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni Nemocnice Brno /ID# 154019</name>
      <address>
        <city>Brno</city>
        <zip>625 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Hradec Kralove /ID# 154021</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>500 05</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Ostrava /ID# 154017</name>
      <address>
        <city>Ostrava</city>
        <zip>708 52</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Plzen /ID# 154018</name>
      <address>
        <city>Plzen</city>
        <zip>305 99</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aalborg University Hospital /ID# 154047</name>
      <address>
        <city>Aalborg</city>
        <state>Nordjylland</state>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampere University Hospital /ID# 154963</name>
      <address>
        <city>Tampere</city>
        <state>Pirkanmaa</state>
        <zip>33520</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helsinki University Hospital /ID# 155223</name>
      <address>
        <city>Helsinki</city>
        <state>Uusimaa</state>
        <zip>00290</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Turku University Hospital /ID# 154964</name>
      <address>
        <city>Turku</city>
        <zip>20520</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Bordeaux - Hopital Haut Leveque /ID# 153789</name>
      <address>
        <city>Pessac</city>
        <state>Gironde</state>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Angers /Id# 153792</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AP-HP - Hopital Saint-Louis /ID# 153787</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IUCT Oncopole /ID# 153788</name>
      <address>
        <city>Toulouse Cedex 9</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Ulm /ID# 153054</name>
      <address>
        <city>Ulm</city>
        <state>Baden-Wuerttemberg</state>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Frankfurt /ID# 153060</name>
      <address>
        <city>Frankfurt am Main</city>
        <state>Hessen</state>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Muenster /ID# 153059</name>
      <address>
        <city>Muenster</city>
        <state>Nordrhein-Westfalen</state>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Halle (Saale) /ID# 153058</name>
      <address>
        <city>Halle (Saale)</city>
        <zip>06120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 153056</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover /ID# 153055</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 153812</name>
      <address>
        <city>Szeged</city>
        <state>Csongrad</state>
        <zip>6725</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem Klinikai Kozpont /ID# 153814</name>
      <address>
        <city>Debrecen</city>
        <state>Hajdu-Bihar</state>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Josa Andras Okta /ID# 169854</name>
      <address>
        <city>Nyíregyháza</city>
        <state>Nyiregyhaza</state>
        <zip>4400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 153813</name>
      <address>
        <city>Kaposvár</city>
        <state>Somogy</state>
        <zip>7400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Semmelweis Egyetem /ID# 153816</name>
      <address>
        <city>Budapest</city>
        <zip>1085</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duplicate_Semmelweis Egyetem /ID# 153815</name>
      <address>
        <city>Budapest</city>
        <zip>1088</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 158990</name>
      <address>
        <city>Budapest</city>
        <zip>1097</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Chaim Sheba Medical Center /ID# 154173</name>
      <address>
        <city>Ramat Gan</city>
        <state>Tel-Aviv</state>
        <zip>5265601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center /ID# 154175</name>
      <address>
        <city>Tel Aviv-Yafo</city>
        <state>Tel-Aviv</state>
        <zip>6423906</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Assaf Harofeh Medical Center /ID# 158063</name>
      <address>
        <city>Be'er Ya'aqov</city>
        <zip>70300</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Health Care Campus /ID# 154174</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah /ID# 154172</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center /ID# 154176</name>
      <address>
        <city>Petach Tikva</city>
        <zip>4941492</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Presidio Ospedaliero Vito Fazzi /ID# 170837</name>
      <address>
        <city>Lecce</city>
        <state>Puglia</state>
        <zip>73100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione PTV Policlinico Tor Vergata /ID# 152881</name>
      <address>
        <city>Rome</city>
        <state>Roma</state>
        <zip>00133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 171220</name>
      <address>
        <city>Ancona</city>
        <zip>60126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 152875</name>
      <address>
        <city>Bergamo</city>
        <zip>24127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 152883</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Policlinico San Martino /ID# 158104</name>
      <address>
        <city>Genova</city>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 152882</name>
      <address>
        <city>Milan</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 152879</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 152877</name>
      <address>
        <city>Reggio Calabria</city>
        <zip>89124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria Sant'Andrea /ID# 152876</name>
      <address>
        <city>Rome</city>
        <zip>00189</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aichi Cancer Center Hospital /ID# 200824</name>
      <address>
        <city>Nagoya-shi</city>
        <state>Aichi</state>
        <zip>464-8681</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Fukui Hospital /ID# 167432</name>
      <address>
        <city>Yoshida-gun</city>
        <state>Fukui</state>
        <zip>910-1193</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kyushu Cancer Center /ID# 201111</name>
      <address>
        <city>Fukuoka-shi</city>
        <state>Fukuoka</state>
        <zip>811-1395</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyushu University Hospital /ID# 169095</name>
      <address>
        <city>Fukuoka-shi</city>
        <state>Fukuoka</state>
        <zip>812-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gunmaken Saiseikai Maebashi Hospital /ID# 168316</name>
      <address>
        <city>Maebashi-shi</city>
        <state>Gunma</state>
        <zip>371-0821</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Mito Medical Center /ID# 168219</name>
      <address>
        <city>Higashi</city>
        <state>Ibaraki</state>
        <zip>311-3193</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hitachi General Hospital /ID# 201109</name>
      <address>
        <city>Hitachi-shi</city>
        <state>Ibaraki</state>
        <zip>317-0077</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duplicate_Kyoto Prefectural University of Medicine /ID# 167661</name>
      <address>
        <city>Kyoto-shi</city>
        <state>Kyoto</state>
        <zip>602-8566</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tohoku University Hospital /ID# 169259</name>
      <address>
        <city>Sendai-shi</city>
        <state>Miyagi</state>
        <zip>9808574</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagasaki University Hospital /ID# 168632</name>
      <address>
        <city>Nagasaki-shi</city>
        <state>Nagasaki</state>
        <zip>852-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okayama University Hospital /ID# 204124</name>
      <address>
        <city>Okayama-shi</city>
        <state>Okayama</state>
        <zip>700-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duplicate_Kindai University Hospital /ID# 167662</name>
      <address>
        <city>Osaka-sayama-shi</city>
        <state>Osaka</state>
        <zip>589-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka Metropolitan University Hospital /ID# 169055</name>
      <address>
        <city>Osaka-shi</city>
        <state>Osaka</state>
        <zip>545-8586</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Medical University International Medical Center /ID# 167814</name>
      <address>
        <city>Hidaka-shi</city>
        <state>Saitama</state>
        <zip>350-1298</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juntendo University Hospital /ID# 168309</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>113-8431</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 168639</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>113-8677</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Jikei University Daisan Hospital /ID# 168745</name>
      <address>
        <city>Komae-shi</city>
        <state>Tokyo</state>
        <zip>201-8601</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NTT Medical Center Tokyo /ID# 167975</name>
      <address>
        <city>Shinagawa-ku</city>
        <state>Tokyo</state>
        <zip>141-8625</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yamagata University Hospital /ID# 167634</name>
      <address>
        <city>Yamagata-shi</city>
        <state>Yamagata</state>
        <zip>990-9585</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duplicate_Konkuk University Medical Ctr /ID# 153973</name>
      <address>
        <city>Seoul</city>
        <state>Seoul Teugbyeolsi</state>
        <zip>05030</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital /ID# 153675</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center /ID# 153674</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akershus universitetssykehus /ID# 154279</name>
      <address>
        <city>Nordlenangen</city>
        <state>Akershus</state>
        <zip>1474</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drammen Sykehus /ID# 154280</name>
      <address>
        <city>Drammen</city>
        <state>Buskerud</state>
        <zip>3004</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haukeland University Hospital /ID# 154281</name>
      <address>
        <city>Bergen</city>
        <state>Hordaland</state>
        <zip>5021</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sykehuset Ostfold Kalnes /ID# 157755</name>
      <address>
        <city>Gralum</city>
        <zip>1714</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu /ID# 153389</name>
      <address>
        <city>Wroclaw</city>
        <state>Dolnoslaskie</state>
        <zip>50-556</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osrodek Badan Klinicznych przy Szpitalu Specjalistycznym im. Ludwika Rydygiera w /ID# 169846</name>
      <address>
        <city>Krakow</city>
        <state>Malopolskie</state>
        <zip>31-826</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SP ZOZ Zespol Szpitali Miejskich w Chorzowie /ID# 153385</name>
      <address>
        <city>Chorzow</city>
        <state>Slaskie</state>
        <zip>41-500</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duplicate_Hospital de Braga /ID# 154797</name>
      <address>
        <city>Braga</city>
        <zip>4710-423</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IPO Porto FG, EPE /ID# 154138</name>
      <address>
        <city>Porto</city>
        <zip>4200-072</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Caribbean Healthcare System /ID# 160507</name>
      <address>
        <city>San Juan</city>
        <zip>00921-3201</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kuzbass Regional Clinical Hospital /ID# 157461</name>
      <address>
        <city>Kemerovo</city>
        <state>Kemerovskaya Oblast</state>
        <zip>650099</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moscow State budget healthcare /ID# 155738</name>
      <address>
        <city>Moscow</city>
        <state>Moskva</state>
        <zip>125284</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nizhny Novgorod Regional Clinical Hospital named N.A. Semashko /ID# 153268</name>
      <address>
        <city>Nizhniy Novgorod</city>
        <state>Nizhegorodskaya Oblast</state>
        <zip>603126</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duplicate_Regional Oncology Dispensary /ID# 153264</name>
      <address>
        <city>Penza</city>
        <state>Penzenskaya Oblast</state>
        <zip>440071</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 157460</name>
      <address>
        <city>Ryazan</city>
        <state>Ryazanskaya Oblast</state>
        <zip>390039</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saratov State Medical University n.a. V.I. Razumovskiy /ID# 153267</name>
      <address>
        <city>Saratov</city>
        <state>Saratovskaya Oblast</state>
        <zip>410012</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal State Budgetary Ins NRC for Hematology of MoH of Russian Federation /ID# 155740</name>
      <address>
        <city>Moscow</city>
        <zip>125167</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samara State Medical University /ID# 157462</name>
      <address>
        <city>Samara</city>
        <zip>443099</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pretoria /ID# 153682</name>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0001</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albert Alberts Stem Cell Transplant Centre /ID# 153684</name>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0044</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Navarra /ID# 153254</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic de Barcelona /ID# 153255</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Creu i Sant Pau /ID# 153193</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de la Princesa /ID# 153256</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Maranon /ID# 153260</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre /ID# 153258</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de la Victoria /ID# 153257</name>
      <address>
        <city>Malaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario y Politecnico La Fe /ID# 153259</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akademiska Sjukhuset /ID# 153034</name>
      <address>
        <city>Uppsala</city>
        <state>Uppsala Lan</state>
        <zip>751 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uddevalla sjukhus /ID# 156875</name>
      <address>
        <city>Uddevalla</city>
        <state>Vastra Gotalands Lan</state>
        <zip>451 80</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dup_VO Hematologi /ID# 153174</name>
      <address>
        <city>Lund</city>
        <zip>221 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska University Hospital /ID# 170003</name>
      <address>
        <city>Stockholm</city>
        <zip>171 76</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Changhua Christian Hospital /ID# 153899</name>
      <address>
        <city>Changhua city</city>
        <state>Changhua County</state>
        <zip>50006</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 153902</name>
      <address>
        <city>Kaohsiung</city>
        <zip>807</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital /ID# 153904</name>
      <address>
        <city>Taichung City</city>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital /ID# 153900</name>
      <address>
        <city>Taipei City</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hacettepe University Faculty of Medicine /ID# 202073</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ankara Universitesi Fakultesi /ID# 155200</name>
      <address>
        <city>Ankara</city>
        <zip>06620</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ondokuz Mayis Universitesi Tip /ID# 155201</name>
      <address>
        <city>Samsun</city>
        <zip>55139</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyiv city clinical hospital #9 /ID# 153510</name>
      <address>
        <city>Kiev</city>
        <state>Vinnytska Oblast</state>
        <zip>04112</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council /ID# 153511</name>
      <address>
        <city>Dnipro</city>
        <zip>49102</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyiv Regional Onco Dispensary /ID# 153514</name>
      <address>
        <city>Kyiv</city>
        <zip>04107</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Poltava Reg Clin Hosp Sklifoso /ID# 153513</name>
      <address>
        <city>Poltava</city>
        <zip>36011</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>China</country>
    <country>Croatia</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Norway</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Puerto Rico</country>
    <country>Russian Federation</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Taiwan</country>
    <country>Turkey</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://rxabbvie.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <results_first_submitted>November 28, 2022</results_first_submitted>
  <results_first_submitted_qc>January 11, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">January 27, 2023</results_first_posted>
  <last_update_submitted>June 27, 2023</last_update_submitted>
  <last_update_submitted_qc>June 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute Myeloid Leukemia</keyword>
  <keyword>Venetoclax</keyword>
  <keyword>Treatment Naïve</keyword>
  <keyword>Azacitidine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azacitidine</mesh_term>
    <mesh_term>Venetoclax</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/</ipd_time_frame>
    <ipd_access_criteria>Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/abbvie/</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 1, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT02993523/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 3, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT02993523/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were randomized in Group 1 per original protocol stratified by age (18 - &lt; 75, ≥ 75), and region (US, EU, Japan (JP), Rest of world (ROW)) and Group 2 during or after Amendment 1 stratified by age (18 - &lt; 75, ≥ 75), cytogenetic risk (intermediate, poor) and region (US, EU, China, JP, ROW).</recruitment_details>
      <pre_assignment_details>Total of 443 participants were enrolled. 433 participants were randomized in Group 1 and Group 2 to receive placebo or venetoclax 100/200/400mg+azacitidine 75mg/m^2. 10 participants in open-label China cohort received venetoclax 400 mg + azacitidine 75 mg/m^2 up to data cut-off date: 01 December 2021. This study is ongoing.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Group 1: Placebo + Azacitidine 75 mg/m^2</title>
          <description>Participants enrolled under original protocol received venetoclax-matching placebo, orally, once daily (QD), from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, subcutaneously (SC) or intravenously (IV), QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).</description>
        </group>
        <group group_id="P2">
          <title>Group 1: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2</title>
          <description>Participants enrolled under original protocol received venetoclax 100 mg, once orally, on Day 1 of Cycle 1 followed by venetoclax 200 mg, once orally, on Day 2 of Cycle 1 and venetoclax 400 mg, orally, QD, on Day 3 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).</description>
        </group>
        <group group_id="P3">
          <title>Group 2: Placebo + Azacitidine 75 mg/m^2</title>
          <description>Participants received venetoclax-matching placebo, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).</description>
        </group>
        <group group_id="P4">
          <title>Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2</title>
          <description>Participants received venetoclax 100 mg, once orally, on Day 1 of Cycle 1 followed by venetoclax 200 mg, once orally, on Day 2 of Cycle 1 and venetoclax 400 mg, orally, QD, from Day 3 to Day 28 of each 28-day cycle along with azacitidine 75 mg/m^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).</description>
        </group>
        <group group_id="P5">
          <title>Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2</title>
          <description>Participants received venetoclax 400 mg, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="145"/>
                <participants group_id="P4" count="286"/>
                <participants group_id="P5" count="10"/>
              </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="1"/>
                <participants group_id="P4" count="48"/>
                <participants group_id="P5" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="144"/>
                <participants group_id="P4" count="238"/>
                <participants group_id="P5" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrew Consent</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="9"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="138"/>
                <participants group_id="P4" count="222"/>
                <participants group_id="P5" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Reason not Specified</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 group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full Analysis Set included all Group 1 and 2 participants randomized by Interactive Voice Response System (IVRS)/Interactive Web Response System (IWRS) (exclude the open-label China safety cohort). Open-Label China Safety Cohort included participants who received at least one dose of venetoclax.</population>
      <group_list>
        <group group_id="B1">
          <title>Group 1: Placebo + Azacitidine 75 mg/m^2</title>
          <description>Participants enrolled under original protocol received venetoclax-matching placebo, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).</description>
        </group>
        <group group_id="B2">
          <title>Group 1: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2</title>
          <description>Participants enrolled under original protocol received venetoclax 100 mg, once orally, on Day 1 of Cycle 1 followed by venetoclax 200 mg, once orally, on Day 2 of Cycle 1 and venetoclax 400 mg, orally, QD, on Day 3 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).</description>
        </group>
        <group group_id="B3">
          <title>Group 2: Placebo + Azacitidine 75 mg/m^2</title>
          <description>Participants received venetoclax-matching placebo, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).</description>
        </group>
        <group group_id="B4">
          <title>Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2</title>
          <description>Participants received venetoclax 100 mg, once orally, on Day 1 of Cycle 1 followed by venetoclax 200 mg, once orally, on Day 2 of Cycle 1 and venetoclax 400 mg, orally, QD, from Day 3 to Day 28 of each 28-day cycle along with azacitidine 75 mg/m^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).</description>
        </group>
        <group group_id="B5">
          <title>Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2</title>
          <description>Participants received venetoclax 400 mg, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).</description>
        </group>
        <group group_id="B6">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
            <count group_id="B2" value="1"/>
            <count group_id="B3" value="145"/>
            <count group_id="B4" value="286"/>
            <count group_id="B5" value="10"/>
            <count group_id="B6" value="443"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.0" spread="NA">Standard deviation (SD) was not estimable for 1 participant.</measurement>
                    <measurement group_id="B2" value="65.0" spread="NA">SD was not estimable for 1 participant.</measurement>
                    <measurement group_id="B3" value="75.1" spread="5.70"/>
                    <measurement group_id="B4" value="75.6" spread="6.08"/>
                    <measurement group_id="B5" value="70.2" spread="7.44"/>
                    <measurement group_id="B6" value="75.2" spread="6.08"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="58"/>
                    <measurement group_id="B4" value="114"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="177"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="87"/>
                    <measurement group_id="B4" value="172"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="266"/>
                  </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="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="66"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="109"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="109"/>
                    <measurement group_id="B4" value="217"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="327"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Survival (OS)</title>
        <description>OS is defined as the number of days from the date of randomization to the date of death. Log rank test was used to compare the OS distribution between two treatment arms. Cox regression was used to report the hazard ratio.</description>
        <time_frame>From the study start up to death or alive or lost to follow-up (up to approximately 4.8 years; data cut off date: 1 December 2021)</time_frame>
        <population>Full Analysis Set included all Group 2 participants randomized by IVRS/IWRS (exclude the open-label China safety cohort).</population>
        <group_list>
          <group group_id="O1">
            <title>Group 2: Placebo + Azacitidine 75 mg/m^2</title>
            <description>Participants received venetoclax-matching placebo, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2</title>
            <description>Participants received venetoclax 100 mg, once orally, on Day 1 of Cycle 1 followed by venetoclax 200 mg, once orally, on Day 2 of Cycle 1 and venetoclax 400 mg, orally, QD, from Day 3 to Day 28 of each 28-day cycle along with azacitidine 75 mg/m^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>OS is defined as the number of days from the date of randomization to the date of death. Log rank test was used to compare the OS distribution between two treatment arms. Cox regression was used to report the hazard ratio.</description>
          <population>Full Analysis Set included all Group 2 participants randomized by IVRS/IWRS (exclude the open-label China safety cohort).</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="145"/>
                <count group_id="O2" value="286"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.6" lower_limit="7.4" upper_limit="12.7"/>
                    <measurement group_id="O2" value="14.7" lower_limit="12.1" upper_limit="18.7"/>
                  </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>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Stratified log-rank test stratified by age (18 - &lt; 75, ≥ 75) and cytogenetic risk (intermediate, poor).</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.580</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.465</ci_lower_limit>
            <ci_upper_limit>0.723</ci_upper_limit>
            <estimate_desc>HR from Cox proportional hazards model stratified by age (18 - &lt; 75, ≥ 75) and cytogenetic risk (intermediate, poor).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Marrow Recovery (CRi)</title>
        <description>CR and CRi was calculated based on current International Working Group (IWG) criteria. CR is defined as absolute neutrophil count &gt;10^3/ microliter (mcL), platelets &gt;10^5/mcL, red cell transfusion independence, and bone marrow with &lt;5% blasts. CRi is defined as bone marrow with less than 5% blasts, and absolute neutrophils of ≤10^3/mcL or platelets ≤10^5/mcL. Percentages are rounded off to whole number at the nearest decimal.</description>
        <time_frame>From the study start up to death (up to approximately 4.8 years; data cut-off date: 1 December 2021)</time_frame>
        <population>Full Analysis Set included all Group 2 participants randomized by IVRS/IWRS (exclude the open-label China safety cohort). Open-Label China Safety Cohort included participants who received at least one dose of venetoclax. Data is reported for Group 2 and Open-label China Cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 2: Placebo + Azacitidine 75 mg/m^2</title>
            <description>Participants received venetoclax-matching placebo, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2</title>
            <description>Participants received venetoclax 100 mg, once orally, on Day 1 of Cycle 1 followed by venetoclax 200 mg, once orally, on Day 2 of Cycle 1 and venetoclax 400 mg, orally, QD, from Day 3 to Day 28 of each 28-day cycle along with azacitidine 75 mg/m^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).</description>
          </group>
          <group group_id="O3">
            <title>Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2</title>
            <description>Participants received venetoclax 400 mg, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Marrow Recovery (CRi)</title>
          <description>CR and CRi was calculated based on current International Working Group (IWG) criteria. CR is defined as absolute neutrophil count &gt;10^3/ microliter (mcL), platelets &gt;10^5/mcL, red cell transfusion independence, and bone marrow with &lt;5% blasts. CRi is defined as bone marrow with less than 5% blasts, and absolute neutrophils of ≤10^3/mcL or platelets ≤10^5/mcL. Percentages are rounded off to whole number at the nearest decimal.</description>
          <population>Full Analysis Set included all Group 2 participants randomized by IVRS/IWRS (exclude the open-label China safety cohort). Open-Label China Safety Cohort included participants who received at least one dose of venetoclax. Data is reported for Group 2 and Open-label China Cohort.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="145"/>
                <count group_id="O2" value="286"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.9" lower_limit="12.1" upper_limit="25.2"/>
                    <measurement group_id="O2" value="38.8" lower_limit="33.1" upper_limit="44.7"/>
                    <measurement group_id="O3" value="60.0" lower_limit="26.2" upper_limit="87.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CRi</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.0" lower_limit="6.4" upper_limit="17.3"/>
                    <measurement group_id="O2" value="28.0" lower_limit="22.8" upper_limit="33.6"/>
                    <measurement group_id="O3" value="20.0" lower_limit="2.5" upper_limit="55.6"/>
                  </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>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Cochran-Mantel-Haenszel (CMH) test stratified by age (18 - &lt; 75, ≥ 75) and cytogenetic risk (intermediate, poor).</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Event-free Survival (EFS)</title>
        <description>EFS will be defined as the number of days from randomization to the date of progressive disease, relapse from CR or CRi, treatment failure or death from any cause.</description>
        <time_frame>Measured up to 2 years after the last participant is randomized</time_frame>
        <posting_date>09/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Global Health Status/Quality of Life (GHS/QoL)</title>
        <description>Improvement in GHS/QoL will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30).</description>
        <time_frame>Measured at participant's Day 1 of Cycle 1 (each cycle is 28 days) and at Day 1 of every Cycle thereafter for up to 2 years following the last subject last visit</time_frame>
        <posting_date>09/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Composite Complete Remission (CR or CRi)</title>
        <description>This will be calculated based on current International Working Group (IWG) criteria. CR is defined as absolute neutrophil count &gt; 10^3/mcL, platelets &gt; 10^5/mcL, red cell transfusion independence, and bone marrow with &lt; 5% blasts. CRi is defined as bone marrow with less than 5% blasts, and absolute neutrophils of &lt;= 10^3/mcL or platelets &lt;= 10^5/mcL.</description>
        <time_frame>Up to 6 months after the first 225 participants are randomized</time_frame>
        <posting_date>09/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Complete Remission or Complete Remission With Partial Hematologic Recovery Rate (CR+CRh)</title>
        <description>A response of CRh is defined as Bone marrow with &lt;5% blasts, peripheral blood neutrophil count &gt;0.5*10^3/mcL and peripheral blood platelet count &gt;0.5*10^5/mcL.</description>
        <time_frame>Measured up to 2 years after the last participant is randomized</time_frame>
        <posting_date>09/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post Baseline Transfusion Independence Rate</title>
        <description>Transfusion Independence is defined as a period of 56 days with no transfusion between first dose of study drug and the last dose of study drug + 30 days. The rate of conversion for red blood cells (RBC) and platelets is defined as percentage of participants being post-baseline transfusion independent from baseline transfusion dependence.</description>
        <time_frame>Measured up to 2 years after the last participant is randomized</time_frame>
        <posting_date>09/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Complete Remission (CR) Rate</title>
        <description>The percentage of participants with complete remission (CR) will be calculated based on the modified IWG criteria for AML.</description>
        <time_frame>Measured up to 2 years after the last participant is randomized</time_frame>
        <posting_date>09/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fatigue/Quality of Life (QoL)</title>
        <description>Fatigue QoL will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Fatigue Short Form (SF) 7a global fatigue score</description>
        <time_frame>Measured at participant's Day 1 of Cycle 1 (each cycle is 28 days) and at Day 1 of every Cycle thereafter for up to 2 years following the last participant last visit</time_frame>
        <posting_date>09/2024</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the study start until data cut-off date: 01 December 2021 (up to approximately 4.8 years)</time_frame>
      <desc>Safety analysis set included all Group 1 and Group 2 participants (exclude the open-label China safety cohort) who took at least one dose of venetoclax/placebo and azacitidine combination. As pre-specified in SAP the data is reported combined for both Group 1 and Group 2 participants who received either placebo plus azacitidine or venetoclax plus azacitidine. Open-Label China Safety Cohort included participants who received at least one dose of venetoclax in combination with azacitidine.</desc>
      <group_list>
        <group group_id="E1">
          <title>Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2</title>
          <description>Participants enrolled under original protocol and enrolled during or after protocol amendment 1 received venetoclax-matching placebo, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).</description>
        </group>
        <group group_id="E2">
          <title>Group 1 and Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2</title>
          <description>Participants enrolled under original protocol and enrolled during or after protocol amendment 1 received venetoclax 100 mg, once orally, on Day 1 of Cycle 1 followed by venetoclax 200 mg, once orally, on Day 2 of Cycle 1 and venetoclax 400 mg, orally, QD, on Day 3 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).</description>
        </group>
        <group group_id="E3">
          <title>Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2</title>
          <description>Participants received venetoclax 400 mg, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.0</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="140" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="226" subjects_at_risk="283"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="111" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="242" subjects_at_risk="283"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>ANAEMIA</sub_title>
                <counts group_id="E1" events="13" subjects_affected="9" subjects_at_risk="144"/>
                <counts group_id="E2" events="23" subjects_affected="19" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CYTOPENIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>DISSEMINATED INTRAVASCULAR COAGULATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>FEBRILE NEUTROPENIA</sub_title>
                <counts group_id="E1" events="21" subjects_affected="15" subjects_at_risk="144"/>
                <counts group_id="E2" events="132" subjects_affected="88" subjects_at_risk="283"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HAEMOLYSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>LEUKOCYTOSIS</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>LEUKOPENIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>NEUTROPENIA</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="144"/>
                <counts group_id="E2" events="15" subjects_affected="14" subjects_at_risk="283"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PANCYTOPENIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>THROMBOCYTOPENIA</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="144"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="283"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="10"/>
              </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="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ACUTE MYOCARDIAL INFARCTION</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ANGINA PECTORIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ANGINA UNSTABLE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ATRIAL FIBRILLATION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E2" events="15" subjects_affected="13" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ATRIAL FLUTTER</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ATRIOVENTRICULAR BLOCK</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CARDIAC ARREST</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CARDIAC FAILURE</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="144"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CARDIAC FAILURE ACUTE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CARDIAC FAILURE CONGESTIVE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CARDIAC TAMPONADE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CARDIO-RESPIRATORY ARREST</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CARDIOVASCULAR DISORDER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CARDIOVASCULAR INSUFFICIENCY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ISCHAEMIC CARDIOMYOPATHY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>LEFT VENTRICULAR DYSFUNCTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>MYOCARDIAL INFARCTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>MYOCARDIAL ISCHAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>MYOCARDIAL OEDEMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PERICARDIAL EFFUSION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PERICARDITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>RIGHT VENTRICULAR FAILURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>SUPRAVENTRICULAR EXTRASYSTOLES</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>SUPRAVENTRICULAR TACHYCARDIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>TORSADE DE POINTES</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>VENTRICULAR TACHYCARDIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>VERTIGO</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL PAIN UPPER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ANAL FISTULA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>COLITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>COLITIS ISCHAEMIC</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="144"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>DYSPEPSIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ENTEROCOLITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>GASTRITIS HAEMORRHAGIC</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>GASTRODUODENITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>GASTROINTESTINAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HAEMATEMESIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HAEMORRHOIDS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HYPERTROPHIC ANAL PAPILLA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ILEUS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ILEUS PARALYTIC</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>INGUINAL HERNIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>INTESTINAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>INTESTINAL OBSTRUCTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>LOWER GASTROINTESTINAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>MELAENA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>NECROTISING COLITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>NEUTROPENIC COLITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PALATAL ULCER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PANCREATITIS ACUTE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PROCTALGIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PROCTITIS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>RECTAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>SMALL INTESTINAL OBSTRUCTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>STOMATITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>ASTHENIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CATHETER SITE HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CHILLS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>DEATH</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>DISCOMFORT</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>GENERAL PHYSICAL HEALTH DETERIORATION</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="144"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>IMPAIRED SELF-CARE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>INCARCERATED HERNIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>INJECTION SITE EXTRAVASATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>INJECTION SITE INFLAMMATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>MUCOSAL INFLAMMATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>MULTIPLE ORGAN DYSFUNCTION SYNDROME</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>NON-CARDIAC CHEST PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>OEDEMA PERIPHERAL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PERIPHERAL SWELLING</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PYREXIA</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="144"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>SUDDEN CARDIAC DEATH</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>SUDDEN DEATH</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>SYSTEMIC INFLAMMATORY RESPONSE SYNDROME</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>CHOLECYSTITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CHOLECYSTITIS ACUTE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CHOLELITHIASIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HEPATIC CONGESTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HEPATIC FUNCTION ABNORMAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HEPATITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HEPATITIS ACUTE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HEPATITIS CHOLESTATIC</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>DRUG HYPERSENSITIVITY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>ABSCESS FUNGAL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ABSCESS LIMB</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ACINETOBACTER BACTERAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ACUTE SINUSITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ALVEOLAR OSTEITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ANAL ABSCESS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ANORECTAL CELLULITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ASPERGILLUS INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ATYPICAL PNEUMONIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>BACTERAEMIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="9" subjects_affected="7" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>BRONCHIOLITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>BRONCHITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>BRONCHITIS BACTERIAL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>BRONCHITIS MORAXELLA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>BRONCHITIS VIRAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>BRONCHOPULMONARY ASPERGILLOSIS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>BURKHOLDERIA INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CAMPYLOBACTER GASTROENTERITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CANDIDA SEPSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CANDIDURIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CELLULITIS</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="144"/>
                <counts group_id="E2" events="9" subjects_affected="7" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CELLULITIS OF MALE EXTERNAL GENITAL ORGAN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CELLULITIS ORBITAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CELLULITIS STAPHYLOCOCCAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CITROBACTER INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CLOSTRIDIAL SEPSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CLOSTRIDIUM DIFFICILE COLITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CORONA VIRUS INFECTION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>DERMATITIS INFECTED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>DIVERTICULITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="9" subjects_affected="6" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>EAR INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ENDOCARDITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ENTEROBACTER PNEUMONIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ENTEROCOCCAL INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ENTEROCOCCAL SEPSIS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ERYSIPELAS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ESCHERICHIA BACTERAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ESCHERICHIA INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ESCHERICHIA SEPSIS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ESCHERICHIA URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>EYE INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>FUNGAL SEPSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>GASTROENTERITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>GASTROENTERITIS SALMONELLA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>GASTROINTESTINAL INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>GINGIVITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HERPES SIMPLEX</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>INFECTIOUS PLEURAL EFFUSION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>INFECTIOUS THYROIDITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>INFLUENZA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>INTERVERTEBRAL DISCITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>KLEBSIELLA BACTERAEMIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>KLEBSIELLA INFECTION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>KLEBSIELLA SEPSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>LIVER ABSCESS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>LUNG INFECTION</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="144"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="283"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>MEDICAL DEVICE SITE CELLULITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>MENINGITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>NEUTROPENIC SEPSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ORAL HERPES</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ORCHITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>OROPHARYNGEAL CANDIDIASIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>OSTEOMYELITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>OTITIS MEDIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PARAINFLUENZAE VIRUS INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PAROTITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PERICORONITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PHARYNGITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PHARYNGOTONSILLITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PNEUMOCYSTIS JIROVECII INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PNEUMONIA</sub_title>
                <counts group_id="E1" events="46" subjects_affected="35" subjects_at_risk="144"/>
                <counts group_id="E2" events="71" subjects_affected="55" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PNEUMONIA FUNGAL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PNEUMONIA KLEBSIELLA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PNEUMONIA PNEUMOCOCCAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PNEUMONIA VIRAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>POST PROCEDURAL INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PROTEUS INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PSEUDOMONAL BACTERAEMIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PSEUDOMONAL SEPSIS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PSEUDOMONAS INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PSOAS ABSCESS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PULMONARY MYCOSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PULMONARY NOCARDIOSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PULPITIS DENTAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>RECTAL ABSCESS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>RESPIRATORY SYNCYTIAL VIRUS INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>RESPIRATORY TRACT INFECTION VIRAL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>RHINITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>RHINOVIRUS INFECTION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>SEPSIS</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="144"/>
                <counts group_id="E2" events="29" subjects_affected="20" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>SEPTIC SHOCK</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="11" subjects_affected="8" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>SINUSITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>SKIN INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>SOFT TISSUE INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>STAPHYLOCOCCAL BACTERAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>STAPHYLOCOCCAL INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>STAPHYLOCOCCAL SEPSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>STREPTOCOCCAL BACTERAEMIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>STREPTOCOCCAL SEPSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>SUBCUTANEOUS ABSCESS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>SYSTEMIC CANDIDA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>SYSTEMIC INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>SYSTEMIC MYCOSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>TONSILLITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>TOOTH ABSCESS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="144"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION BACTERIAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION ENTEROCOCCAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>UROSEPSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>VASCULAR DEVICE INFECTION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>WATERHOUSE-FRIDERICHSEN SYNDROME</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>WOUND INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>WOUND INFECTION STAPHYLOCOCCAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>ARTERIAL BYPASS OCCLUSION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>EXTRADURAL HAEMATOMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>FACIAL BONES FRACTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>FALL</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="144"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>FEMORAL NECK FRACTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HEAD INJURY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HUMERUS FRACTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>INCISION SITE HAEMATOMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>INJURY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>LACERATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>LIGAMENT SPRAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>LUMBAR VERTEBRAL FRACTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PELVIC FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PUBIS FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>SPINAL FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>SUBARACHNOID HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>SUBDURAL HAEMATOMA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>SUBDURAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>TRANSFUSION REACTION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>VASCULAR PSEUDOANEURYSM</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>WOUND</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>ALANINE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ASPARTATE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>BLOOD BILIRUBIN INCREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>BLOOD CREATININE INCREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>C-REACTIVE PROTEIN INCREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CLOSTRIDIUM TEST POSITIVE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>COMPUTERISED TOMOGRAM HEAD ABNORMAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>GENERAL PHYSICAL CONDITION ABNORMAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>NEUTROPHIL COUNT DECREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PLATELET COUNT DECREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>POLYOMAVIRUS TEST POSITIVE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>STAPHYLOCOCCUS TEST POSITIVE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>WEIGHT DECREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>WHITE BLOOD CELL COUNT INCREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>DECREASED APPETITE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>DEHYDRATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>FAILURE TO THRIVE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HYPERKALAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HYPERNATRAEMIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HYPONATRAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HYPOVOLAEMIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>METABOLIC ACIDOSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>TUMOUR LYSIS SYNDROME</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ARTHRITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>BACK PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CHONDROCALCINOSIS PYROPHOSPHATE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>NECK PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>OSTEOARTHRITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PAIN IN EXTREMITY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>RHEUMATOID ARTHRITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>SERONEGATIVE ARTHRITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>SOFT TISSUE HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>ADENOCARCINOMA OF COLON</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>BRAIN NEOPLASM</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ERYTHROLEUKAEMIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HEPATIC CANCER STAGE IV</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>MALIGNANT MELANOMA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>MALIGNANT NEOPLASM PROGRESSION</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>RENAL CANCER</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>SQUAMOUS CELL CARCINOMA OF SKIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>CEREBRAL HAEMATOMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CEREBRAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CEREBRAL INFARCTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CEREBROVASCULAR ACCIDENT</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>COMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>DEPRESSED LEVEL OF CONSCIOUSNESS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>DYSARTHRIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ENCEPHALOPATHY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HAEMORRHAGE INTRACRANIAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HAEMORRHAGIC STROKE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HEMIPARESIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ISCHAEMIC STROKE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>MOTOR NEURONE DISEASE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PARESIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PERIPHERAL SENSORIMOTOR NEUROPATHY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PRESYNCOPE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>SEIZURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>SYNCOPE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>CONFUSIONAL STATE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>DELIRIUM</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>DEPRESSION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>MENTAL STATUS CHANGES</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </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="5" subjects_affected="5" subjects_at_risk="144"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>AZOTAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CHRONIC KIDNEY DISEASE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HAEMATURIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HAEMORRHAGE URINARY TRACT</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>RENAL FAILURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>RENAL MASS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>STRANGURY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>URINARY RETENTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE RESPIRATORY DISTRESS SYNDROME</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ACUTE RESPIRATORY FAILURE</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ASPIRATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>EMPHYSEMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>EPISTAXIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HAEMOPTYSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HYPOXIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>LUNG CONSOLIDATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>LUNG DISORDER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PLEURAL EFFUSION</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PNEUMONITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PNEUMOTHORAX</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PNEUMOTHORAX SPONTANEOUS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PULMONARY ARTERY THROMBOSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PULMONARY EMBOLISM</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PULMONARY OEDEMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>RESPIRATORY DISTRESS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>RESPIRATORY FAILURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ERYTHEMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>RASH ERYTHEMATOUS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>RASH GENERALISED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>RASH PAPULAR</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>RASH PRURITIC</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>ARTERIAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CIRCULATORY COLLAPSE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>COELIAC ARTERY OCCLUSION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>DEEP VEIN THROMBOSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HAEMORRHAGIC VASCULITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HYPOTENSION</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ORTHOSTATIC HYPOTENSION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>VENOUS THROMBOSIS LIMB</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21.0</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="137" subjects_at_risk="144"/>
                <counts group_id="E2" subjects_affected="279" subjects_at_risk="283"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>ANAEMIA</sub_title>
                <counts group_id="E1" events="30" subjects_affected="24" subjects_at_risk="144"/>
                <counts group_id="E2" events="102" subjects_affected="68" subjects_at_risk="283"/>
                <counts group_id="E3" events="11" subjects_affected="6" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>FEBRILE NEUTROPENIA</sub_title>
                <counts group_id="E1" events="16" subjects_affected="12" subjects_at_risk="144"/>
                <counts group_id="E2" events="44" subjects_affected="33" subjects_at_risk="283"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>LEUKOPENIA</sub_title>
                <counts group_id="E1" events="46" subjects_affected="20" subjects_at_risk="144"/>
                <counts group_id="E2" events="133" subjects_affected="54" subjects_at_risk="283"/>
                <counts group_id="E3" events="20" subjects_affected="10" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>LYMPHADENOPATHY</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>LYMPHOPENIA</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="144"/>
                <counts group_id="E2" events="16" subjects_affected="8" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>NEUTROPENIA</sub_title>
                <counts group_id="E1" events="66" subjects_affected="38" subjects_at_risk="144"/>
                <counts group_id="E2" events="245" subjects_affected="107" subjects_at_risk="283"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>SPLENIC INFARCTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>THROMBOCYTOPENIA</sub_title>
                <counts group_id="E1" events="94" subjects_affected="57" subjects_at_risk="144"/>
                <counts group_id="E2" events="246" subjects_affected="120" subjects_at_risk="283"/>
                <counts group_id="E3" events="15" subjects_affected="6" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ANGINA PECTORIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ATRIAL FIBRILLATION</sub_title>
                <counts group_id="E1" events="15" subjects_affected="13" subjects_at_risk="144"/>
                <counts group_id="E2" events="26" subjects_affected="22" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CARDIAC FAILURE CONGESTIVE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>VESTIBULAR DISORDER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>CATARACT</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CONJUNCTIVAL DISORDER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>KERATITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>OPTIC ATROPHY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>VISION BLURRED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>XEROPHTHALMIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL DISCOMFORT</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="144"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="283"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ABDOMINAL DISTENSION</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="144"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ABDOMINAL PAIN</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="144"/>
                <counts group_id="E2" events="42" subjects_affected="34" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ABDOMINAL PAIN UPPER</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="144"/>
                <counts group_id="E2" events="19" subjects_affected="17" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" events="66" subjects_affected="55" subjects_at_risk="144"/>
                <counts group_id="E2" events="158" subjects_affected="121" subjects_at_risk="283"/>
                <counts group_id="E3" events="9" subjects_affected="7" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" events="65" subjects_affected="46" subjects_at_risk="144"/>
                <counts group_id="E2" events="182" subjects_affected="122" subjects_at_risk="283"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>DYSPEPSIA</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="144"/>
                <counts group_id="E2" events="23" subjects_affected="20" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>FLATULENCE</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="144"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>GINGIVAL PAIN</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="144"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="283"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>GINGIVAL SWELLING</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HAEMORRHOIDS</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="144"/>
                <counts group_id="E2" events="31" subjects_affected="29" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" events="65" subjects_affected="53" subjects_at_risk="144"/>
                <counts group_id="E2" events="178" subjects_affected="123" subjects_at_risk="283"/>
                <counts group_id="E3" events="6" subjects_affected="4" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>STOMATITIS</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="144"/>
                <counts group_id="E2" events="39" subjects_affected="32" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" events="44" subjects_affected="33" subjects_at_risk="144"/>
                <counts group_id="E2" events="128" subjects_affected="84" subjects_at_risk="283"/>
                <counts group_id="E3" events="9" subjects_affected="5" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>ASTHENIA</sub_title>
                <counts group_id="E1" events="17" subjects_affected="12" subjects_at_risk="144"/>
                <counts group_id="E2" events="55" subjects_affected="45" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" events="29" subjects_affected="24" subjects_at_risk="144"/>
                <counts group_id="E2" events="83" subjects_affected="61" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>INJECTION SITE ERYTHEMA</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="144"/>
                <counts group_id="E2" events="19" subjects_affected="17" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>INJECTION SITE REACTION</sub_title>
                <counts group_id="E1" events="14" subjects_affected="11" subjects_at_risk="144"/>
                <counts group_id="E2" events="24" subjects_affected="13" subjects_at_risk="283"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>INJECTION SITE SWELLING</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>MALAISE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E2" events="21" subjects_affected="15" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>OEDEMA PERIPHERAL</sub_title>
                <counts group_id="E1" events="30" subjects_affected="26" subjects_at_risk="144"/>
                <counts group_id="E2" events="96" subjects_affected="70" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PAIN</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="144"/>
                <counts group_id="E2" events="20" subjects_affected="16" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PYREXIA</sub_title>
                <counts group_id="E1" events="43" subjects_affected="30" subjects_at_risk="144"/>
                <counts group_id="E2" events="93" subjects_affected="66" subjects_at_risk="283"/>
                <counts group_id="E3" events="5" subjects_affected="2" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>CHOLECYSTITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HYPERBILIRUBINAEMIA</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="144"/>
                <counts group_id="E2" events="15" subjects_affected="9" subjects_at_risk="283"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="10"/>
              </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="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>ANAL INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>GASTROINTESTINAL FUNGAL INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>GINGIVITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>LUNG INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="283"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ORAL CANDIDIASIS</sub_title>
                <counts group_id="E1" events="8" subjects_affected="5" subjects_at_risk="144"/>
                <counts group_id="E2" events="21" subjects_affected="17" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ORAL HERPES</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="144"/>
                <counts group_id="E2" events="18" subjects_affected="17" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PERITONITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PNEUMONIA</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="144"/>
                <counts group_id="E2" events="19" subjects_affected="19" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>RASH PUSTULAR</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>TINEA INFECTION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="15" subjects_affected="13" subjects_at_risk="144"/>
                <counts group_id="E2" events="29" subjects_affected="25" subjects_at_risk="283"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="144"/>
                <counts group_id="E2" events="34" subjects_affected="22" subjects_at_risk="283"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>BITE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CONTUSION</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="144"/>
                <counts group_id="E2" events="22" subjects_affected="16" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>FALL</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="144"/>
                <counts group_id="E2" events="54" subjects_affected="33" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>ADENOSINE DEAMINASE INCREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ALANINE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="15" subjects_affected="11" subjects_at_risk="144"/>
                <counts group_id="E2" events="34" subjects_affected="24" subjects_at_risk="283"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ASPARTATE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="16" subjects_affected="12" subjects_at_risk="144"/>
                <counts group_id="E2" events="31" subjects_affected="22" subjects_at_risk="283"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>BLOOD ALKALINE PHOSPHATASE INCREASED</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="144"/>
                <counts group_id="E2" events="25" subjects_affected="15" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>BLOOD BILIRUBIN INCREASED</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="144"/>
                <counts group_id="E2" events="28" subjects_affected="21" subjects_at_risk="283"/>
                <counts group_id="E3" events="6" subjects_affected="4" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>BLOOD CREATININE INCREASED</sub_title>
                <counts group_id="E1" events="13" subjects_affected="8" subjects_at_risk="144"/>
                <counts group_id="E2" events="15" subjects_affected="13" subjects_at_risk="283"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>BLOOD LACTATE DEHYDROGENASE INCREASED</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="283"/>
                <counts group_id="E3" events="7" subjects_affected="4" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>C-REACTIVE PROTEIN INCREASED</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="144"/>
                <counts group_id="E2" events="17" subjects_affected="16" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>GAMMA-GLUTAMYLTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E2" events="11" subjects_affected="7" subjects_at_risk="283"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>NEUTROPHIL COUNT DECREASED</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E2" events="12" subjects_affected="7" subjects_at_risk="283"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PLATELET COUNT DECREASED</sub_title>
                <counts group_id="E1" events="9" subjects_affected="3" subjects_at_risk="144"/>
                <counts group_id="E2" events="24" subjects_affected="13" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>WEIGHT DECREASED</sub_title>
                <counts group_id="E1" events="22" subjects_affected="18" subjects_at_risk="144"/>
                <counts group_id="E2" events="61" subjects_affected="42" subjects_at_risk="283"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>DECREASED APPETITE</sub_title>
                <counts group_id="E1" events="29" subjects_affected="26" subjects_at_risk="144"/>
                <counts group_id="E2" events="101" subjects_affected="78" subjects_at_risk="283"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>DIABETES MELLITUS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HYPERGLYCAEMIA</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="144"/>
                <counts group_id="E2" events="14" subjects_affected="12" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HYPERKALAEMIA</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="144"/>
                <counts group_id="E2" events="16" subjects_affected="15" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HYPERPHOSPHATAEMIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HYPERURICAEMIA</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="144"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="283"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HYPOALBUMINAEMIA</sub_title>
                <counts group_id="E1" events="15" subjects_affected="13" subjects_at_risk="144"/>
                <counts group_id="E2" events="31" subjects_affected="23" subjects_at_risk="283"/>
                <counts group_id="E3" events="5" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HYPOCALCAEMIA</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="144"/>
                <counts group_id="E2" events="27" subjects_affected="19" subjects_at_risk="283"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HYPOCHLORAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HYPOKALAEMIA</sub_title>
                <counts group_id="E1" events="59" subjects_affected="43" subjects_at_risk="144"/>
                <counts group_id="E2" events="125" subjects_affected="84" subjects_at_risk="283"/>
                <counts group_id="E3" events="13" subjects_affected="8" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HYPOMAGNESAEMIA</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="144"/>
                <counts group_id="E2" events="28" subjects_affected="24" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HYPONATRAEMIA</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="144"/>
                <counts group_id="E2" events="20" subjects_affected="16" subjects_at_risk="283"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HYPOPHOSPHATAEMIA</sub_title>
                <counts group_id="E1" events="23" subjects_affected="17" subjects_at_risk="144"/>
                <counts group_id="E2" events="46" subjects_affected="36" subjects_at_risk="283"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>LACTIC ACIDOSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>TUMOUR LYSIS SYNDROME</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </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="7" subjects_affected="7" subjects_at_risk="144"/>
                <counts group_id="E2" events="43" subjects_affected="35" subjects_at_risk="283"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ARTHRITIS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>BACK PAIN</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="144"/>
                <counts group_id="E2" events="32" subjects_affected="25" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>JOINT SWELLING</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>MUSCULOSKELETAL PAIN</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="144"/>
                <counts group_id="E2" events="19" subjects_affected="18" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>OSTEOARTHRITIS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PAIN IN EXTREMITY</sub_title>
                <counts group_id="E1" events="19" subjects_affected="15" subjects_at_risk="144"/>
                <counts group_id="E2" events="27" subjects_affected="23" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>SPINAL OSTEOARTHRITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" events="14" subjects_affected="11" subjects_at_risk="144"/>
                <counts group_id="E2" events="51" subjects_affected="37" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>DYSGEUSIA</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="144"/>
                <counts group_id="E2" events="13" subjects_affected="11" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="144"/>
                <counts group_id="E2" events="38" subjects_affected="34" subjects_at_risk="283"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PARAESTHESIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>POOR QUALITY SLEEP</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>INSOMNIA</sub_title>
                <counts group_id="E1" events="17" subjects_affected="15" subjects_at_risk="144"/>
                <counts group_id="E2" events="39" subjects_affected="36" subjects_at_risk="283"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="10"/>
              </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="10" subjects_affected="8" subjects_at_risk="144"/>
                <counts group_id="E2" events="27" subjects_affected="21" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>COUGH</sub_title>
                <counts group_id="E1" events="21" subjects_affected="20" subjects_at_risk="144"/>
                <counts group_id="E2" events="40" subjects_affected="36" subjects_at_risk="283"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>DYSPNOEA</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="144"/>
                <counts group_id="E2" events="49" subjects_affected="37" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>EPISTAXIS</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="144"/>
                <counts group_id="E2" events="30" subjects_affected="24" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>OROPHARYNGEAL PAIN</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="144"/>
                <counts group_id="E2" events="38" subjects_affected="28" subjects_at_risk="283"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PLEURAL EFFUSION</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="144"/>
                <counts group_id="E2" events="29" subjects_affected="27" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>DERMATITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>DRY SKIN</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="144"/>
                <counts group_id="E2" events="20" subjects_affected="17" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ERYTHEMA</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="144"/>
                <counts group_id="E2" events="17" subjects_affected="15" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PETECHIAE</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="144"/>
                <counts group_id="E2" events="19" subjects_affected="18" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PRURIGO</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PRURITUS</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="144"/>
                <counts group_id="E2" events="34" subjects_affected="28" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>RASH</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="144"/>
                <counts group_id="E2" events="40" subjects_affected="31" subjects_at_risk="283"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>RASH ERYTHEMATOUS</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="144"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>RASH MACULO-PAPULAR</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="144"/>
                <counts group_id="E2" events="27" subjects_affected="24" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>AORTIC ARTERIOSCLEROSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>ARTERIOSCLEROSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HAEMATOMA</sub_title>
                <counts group_id="E1" events="14" subjects_affected="9" subjects_at_risk="144"/>
                <counts group_id="E2" events="21" subjects_affected="16" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HYPERTENSION</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="144"/>
                <counts group_id="E2" events="32" subjects_affected="30" subjects_at_risk="283"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>HYPOTENSION</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="144"/>
                <counts group_id="E2" events="31" subjects_affected="23" subjects_at_risk="283"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </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>AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Medical Services</name_or_title>
      <organization>AbbVie</organization>
      <phone>800-633-9110</phone>
      <email>abbvieclinicaltrials@abbvie.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/NCT02993523
org study id: M15-656
secondary id: 2016-001466-28
nct id: NCT02993523
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Acute Myeloid Leukaemia (AML) is an aggressive and rare cancer of myeloid cells (a white
      blood cell responsible for fighting infections). Successful treatment of AML is dependent on
      what subtype of AML the participant has, and the age of the participant when diagnosed.

      Venetoclax is an experimental drug that kills cancer cells by blocking a protein (part of a
      cell) that allows cancer cells to stay alive. This study is designed to see if adding
      venetoclax to azacitidine works better than azacitidine on its own.

      This is a Phase 3, randomized, double-blind (treatment is unknown to participants and
      doctors), placebo controlled study in patients with AML who are >= 18 or more years old and
      have not been treated before. Participants who take part in this study should not be suitable
      for standard induction therapy (usual starting treatment). AbbVie is funding this study which
      will take place at approximately 180 hospitals globally and enroll approximately 400
      participants.

      In this study, 2/3 of participants will receive venetoclax every day with azacitidine and the
      remaining 1/3 will receive placebo (dummy) tablets with azacitidine.

      Participants will continue to have study visits and receive treatment for as long as they are
      having a clinical benefit. The effect of the treatment on AML will be checked by taking
      blood, bone marrow, scans, measuring side effects and by completing health questionnaires.
      Blood and bone marrow tests will be completed to see why some people respond better than
      others. Additional blood tests will be completed for genetic factors and to see how long the
      drug remains in the body.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Overall Survival (OS)
time frame: From the study start up to death or alive or lost to follow-up (up to approximately 4.8 years; data cut off date: 1 December 2021)
description: OS is defined as the number of days from the date of randomization to the date of death. Log rank test was used to compare the OS distribution between two treatment arms. Cox regression was used to report the hazard ratio.
measure: Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Marrow Recovery (CRi)
time frame: From the study start up to death (up to approximately 4.8 years; data cut-off date: 1 December 2021)
description: CR and CRi was calculated based on current International Working Group (IWG) criteria. CR is defined as absolute neutrophil count >10^3/ microliter (mcL), platelets >10^5/mcL, red cell transfusion independence, and bone marrow with <5% blasts. CRi is defined as bone marrow with less than 5% blasts, and absolute neutrophils of ≤10^3/mcL or platelets ≤10^5/mcL. Percentages are rounded off to whole number at the nearest decimal.
measure: Event-free Survival (EFS)
time frame: Measured up to 2 years after the last participant is randomized
description: EFS will be defined as the number of days from randomization to the date of progressive disease, relapse from CR or CRi, treatment failure or death from any cause.
measure: Global Health Status/Quality of Life (GHS/QoL)
time frame: Measured at participant's Day 1 of Cycle 1 (each cycle is 28 days) and at Day 1 of every Cycle thereafter for up to 2 years following the last subject last visit
description: Improvement in GHS/QoL will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30).
measure: Percentage of Participants Achieving Composite Complete Remission (CR or CRi)
time frame: Up to 6 months after the first 225 participants are randomized
description: This will be calculated based on current International Working Group (IWG) criteria. CR is defined as absolute neutrophil count > 10^3/mcL, platelets > 10^5/mcL, red cell transfusion independence, and bone marrow with < 5% blasts. CRi is defined as bone marrow with less than 5% blasts, and absolute neutrophils of <= 10^3/mcL or platelets <= 10^5/mcL.
measure: Complete Remission or Complete Remission With Partial Hematologic Recovery Rate (CR+CRh)
time frame: Measured up to 2 years after the last participant is randomized
description: A response of CRh is defined as Bone marrow with <5% blasts, peripheral blood neutrophil count >0.5*10^3/mcL and peripheral blood platelet count >0.5*10^5/mcL.
measure: Post Baseline Transfusion Independence Rate
time frame: Measured up to 2 years after the last participant is randomized
description: Transfusion Independence is defined as a period of 56 days with no transfusion between first dose of study drug and the last dose of study drug + 30 days. The rate of conversion for red blood cells (RBC) and platelets is defined as percentage of participants being post-baseline transfusion independent from baseline transfusion dependence.
measure: Complete Remission (CR) Rate
time frame: Measured up to 2 years after the last participant is randomized
description: The percentage of participants with complete remission (CR) will be calculated based on the modified IWG criteria for AML.
measure: Fatigue/Quality of Life (QoL)
time frame: Measured at participant's Day 1 of Cycle 1 (each cycle is 28 days) and at Day 1 of every Cycle thereafter for up to 2 years following the last participant last visit
description: Fatigue QoL will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Fatigue Short Form (SF) 7a global fatigue score
arm group label: Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2
arm group type: Placebo Comparator
description: Participants enrolled under original protocol and enrolled during or after protocol amendment 1 received venetoclax-matching placebo, orally, every day (QD), from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, subcutaneously (SC) or intravenously (IV), QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
arm group label: Group 1 and Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2
arm group type: Active Comparator
description: Participants enrolled under original protocol and enrolled during or after protocol amendment 1 received venetoclax 100 mg, once orally, on Day 1 of Cycle 1 followed by venetoclax 200 mg, once orally, on Day 2 of Cycle 1 and venetoclax 400 mg, orally, QD, on Day 3 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
arm group label: Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2
arm group type: Active Comparator
description: Participants received venetoclax 400 mg, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
intervention type: Drug
intervention name: Azacitidine
description: Solution for subcutaneous or intravenous administration.
arm group label: Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2
arm group label: Group 1 and Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2
arm group label: Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2
intervention type: Drug
intervention name: Venetoclax
description: Tablet
arm group label: Group 1 and Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2
arm group label: Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2
other name: ABT-199
intervention type: Drug
intervention name: Placebo
description: Matching placebo tablet
arm group label: Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: ABBVIE INC.
role: Study Director
affiliation: AbbVie
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country: Australia
country: Austria
country: Belgium
country: Brazil
country: Canada
country: China
country: Croatia
country: Czechia
country: Denmark
country: Finland
country: France
country: Germany
country: Hungary
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Norway
country: Poland
country: Portugal
country: Puerto Rico
country: Russian Federation
country: South Africa
country: Spain
country: Sweden
country: Taiwan
country: Turkey
country: Ukraine
country: United States
url: http://rxabbvie.com
description: Related Info
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Azacitidine
mesh term: Venetoclax
sharing ipd: Yes
ipd description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
ipd access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
ipd url: https://vivli.org/ourmember/abbvie/
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 