<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/NCT02242942</url>
  </required_header>
  <id_info>
    <org_study_id>BO25323</org_study_id>
    <secondary_id>2014-001810-24</secondary_id>
    <secondary_id>CLL14</secondary_id>
    <nct_id>NCT02242942</nct_id>
  </id_info>
  <brief_title>Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia</brief_title>
  <official_title>A Prospective, Open-Label, Multicenter Randomized Phase III Trial to Compare The Efficacy and Safety of A Combined Regimen of Obinutuzumab and Venetoclax Versus Obinutuzumab and Chlorambucil in Previously Untreated Patients With CLL and Coexisting Medical Conditions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>German CLL Study Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This open-label, multicenter, randomized Phase III study is designed to compare the efficacy&#xD;
      and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab +&#xD;
      chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical&#xD;
      conditions. The time on study treatment was approximately one year and the follow-up period&#xD;
      will be up to 9 years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 31, 2014</start_date>
  <completion_date type="Anticipated">August 31, 2025</completion_date>
  <primary_completion_date type="Actual">August 17, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression Free Survival (PFS) Based on Investigator Assessment According to IWCLL Criteria</measure>
    <time_frame>Baseline until disease progression or death up to approximately 3.75 years</time_frame>
    <description>PFS was determined according to IWCLL 2008 criteria and defined as the time from randomization to the first occurrence of PD or death from any cause. Disease progression was characterized by at least one of the following: 1) &gt;/= 50% increase in the absolute number of circulating lymphocytes to at least 5*10^9/L, 2) Appearance of new palpable lymph nodes (&gt; 15 mm in longest diameter) or any new extra-nodal lesion; 3) &gt;/= 50% increase in the longest diameter of any previous site of lymphadenopathy; 4) &gt;/= 50% increase in the enlargement of the liver and/or spleen; 5) Transformation to a more aggressive histology.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS) Based on Institutional Review Committee (IRC)-Assessments According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria</measure>
    <time_frame>Baseline until disease progression or death up to approximately 3.75 years</time_frame>
    <description>PFS was determined according to IWCLL 2008 criteria and defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause. Disease progression was characterized by at least one of the following: 1) &gt;/= 50% increase in the absolute number of circulating lymphocytes to at least 5*10^9/L, 2) Appearance of new palpable lymph nodes (&gt; 15 mm in longest diameter) or any new extra-nodal lesion; 3) &gt;/= 50% increase in the longest diameter of any previous site of lymphadenopathy; 4) &gt;/= 50% increase in the enlargement of the liver and/or spleen; 5) Transformation to a more aggressive histology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With an Overall Response (OR) at Completion of Treatment, as Determined by the Investigator According to IWCLL Criteria</measure>
    <time_frame>At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)</time_frame>
    <description>OR was defined as complete response (CR), CR with incomplete bone marrow recovery (CRi), or partial response (PR) according to IWCLL 2008 criteria. CR requires all of the following: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination and computed tomography (CT) scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils &gt;1.5*10^9/L, platelets &gt;100*10^9/L and hemoglobin &gt;110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri). PR: two of the following features for at least 2 months: &gt;/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, &gt;/=50% reduction in lymphadenopathy, &gt;/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils &gt;1.5*10^9/L, platelets &gt;100*10^9/L and hemoglobin &gt;110 g/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a Complete Response Rate (CRR) at the Completion of Treatment Assessment as Determined by the Investigator According to IWCLL Criteria</measure>
    <time_frame>At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)</time_frame>
    <description>CRR was defined as the rate of a clinical response of CR or CRi according to IWCLL 2008 criteria. CR requires all of the following: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination and CT scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils &gt;1.5*10^9/L, platelets &gt;100*10^9/L and hemoglobin &gt;110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Minimal Residual Disease (MRD) Negativity in Peripheral Blood as Measured by Allele-Specific Oligonucleotide Polymerase Chain Reaction (ASO-PCR) at Completion of Treatment</measure>
    <time_frame>At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)</time_frame>
    <description>MRD negativity was defined as having &lt; 1 CLL cell per 10,000 leucocytes in peripheral blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Treatment</measure>
    <time_frame>At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)</time_frame>
    <description>MRD negativity was defined as having &lt; 1 CLL cell per 10,000 leucocytes in bone marrow.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Baseline until death, up to approximately 10.75 years</time_frame>
    <description>OS was defined as the time between the date of randomization and the date of death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With MRD Negativity in Peripheral Blood as Measured by ASO-PCR at Completion of Combination Treatment Assessment</measure>
    <time_frame>Day 1 Cycle 9 or 3 months after last IV infusion, approximately 9 months</time_frame>
    <description>MRD negativity was defined as having &lt; 1 CLL cell per 10,000 leucocytes in peripheral blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Combination Treatment Assessment</measure>
    <time_frame>Day 1 Cycle 9 or 3 months after last IV infusion at approximately 9 months</time_frame>
    <description>MRD negativity was defined as having &lt; 1 CLL cell per 10,000 leucocytes in bone marrow.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With OR at Completion of Combination Treatment Response Assessment</measure>
    <time_frame>Day 1 Cycle 7 or 28 days after last IV infusion, approximately 6 months</time_frame>
    <description>OR was defined as CR, CRi or PR according to IWCLL 2008 criteria. CR required all of the following: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils &gt;1.5*10^9/L, platelets &gt;100*10^9/L and hemoglobin &gt;110 g/L. PR: two of the following features for at least 2 months: &gt;/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, &gt;/=50% reduction in lymphadenopathy, &gt;/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils &gt;1.5*10^9/L, platelets &gt;100*10^9/L and hemoglobin &gt;110 g/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Objective Response (DOR)</measure>
    <time_frame>Time from the first occurrence of a documented objective response to the time of PD as determined by the investigator or death from any cause, up to approximately 10.75 years</time_frame>
    <description>PD was defined as lymphadenopathy, &gt;=50% increase in liver or spleen size, &gt;=50% increase in lymphocyte count, transformation to a more aggressive histology or occurrence of cytopenia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants By Best Response Achieved (CR, CRi, PR, Stable Disease (SD), or PD)</measure>
    <time_frame>Baseline up to the completion of treatment assessment 3 months after treatment completion (up to approximately 15 months)</time_frame>
    <description>CR: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination and CT scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils &gt;1.5*10^9/L, platelets &gt;100*10^9/L and hemoglobin &gt;110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri). PR: any two for at least 2 months: &gt;/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, &gt;/=50% reduction in lymphadenopathy, &gt;/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils &gt;1.5*10^9/L, platelets &gt;100*10^9/L and hemoglobin &gt;110 g/L. PD: lymphadenopathy, &gt;=50% increase in liver or spleen size, &gt;=50% increase in lymphocyte count, transformation to a more aggressive histology or occurrence of cytopenia. SD: a non-response and used to characterize participants who did not achieve a CR or a PR, and who have not exhibited PD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event-Free Survival</measure>
    <time_frame>Time between date of randomization and the date of disease progression/relapse on the basis of investigator-assessment, death, or start of a new anti-leukemic therapy, up to 10.75 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Next Anti-Leukemic Treatment</measure>
    <time_frame>Time between the date of randomization and the date of first intake of new anti-leukemic therapy, up to 10.75 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs)</measure>
    <time_frame>Up to approximately 10.75 years</time_frame>
    <description>An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With CD19 + /CD5+ B Cells or CD14+ Monocytes</measure>
    <time_frame>Baseline up to approximately 10.75 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Human-Anti-Human Antibodies</measure>
    <time_frame>Baseline up to approximately 10.75 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Recorded as Premature Study Withdrawals</measure>
    <time_frame>Up to approximately 10.75 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentrations of Venetoclax</measure>
    <time_frame>Pre-venetoclax dose (0 hour) and 4 hours post- venetoclax dose on Day 1 Cycle 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Concentrations of Obinutuzumab</measure>
    <time_frame>Pre-obinutuzumab infusion (0 hour) and end of obinutuzumab infusion on Day 1 Cycle 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in M.D. Anderson Symptom Inventory-CLL (MDASI-CLL) Score</measure>
    <time_frame>Baseline up to approximately 10.75 years</time_frame>
    <description>The MDASI-CLL is a questionnaire of 25 items related to CLL specific symptoms that a participant may have experienced in the past 24 hours. Participants were asked to rate the severity of 13 symptoms called mean core symptom severity (i.e., pain, fatigue, nausea, disturbed sleep, distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sadness, vomiting, and numbness or tingling), 6 disease-specific symptoms called mean module symptom severity (night sweats, fevers and chills, lymph node swelling, diarrhea, easy bruising or bleeding, and constipation) and 6 mean interference on life questions (i.e., general activity, walking, work, mood, relations with other people, and enjoyment of life) on a scale from 0 to 10 with 0 indicating that the symptom is &quot;not present&quot; or &quot;did not interfere&quot; with the participant's activities and 10 indicating &quot;as bad as you can imagine&quot; or &quot;interfered completely&quot;. Scores were averaged (range 0 to 10) for each of three parts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQC30)</measure>
    <time_frame>Baseline up to approximately 10.75 years</time_frame>
    <description>The EORTC QLQ-C30 is a validated and reliable self-report measure consisting of 30 questions incorporated into five functional scales (physical, role, cognitive, emotional, and social scales), three symptom scales (fatigue, pain, nausea, and vomiting scales), and a global health status/global quality-of-life scale. The remaining single items (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) assess the additional symptoms experienced by patients with cancer and the perceived financial burden of treatment. The 28 function and symptom items were scored on a 4-point scale that ranged from &quot;not at all&quot; to &quot;very much,&quot; and the 2 global health status/global quality-of-life items were scored on a 7-point scale that ranged from &quot;very poor&quot; to &quot;excellent.&quot; Raw average scale scores were linearly transformed to range 0-100 with higher scores indicating higher response levels (i.e., higher functioning, higher symptom severity).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D-3L)</measure>
    <time_frame>Baseline up to approximately 10.75 years</time_frame>
    <description>The EQ-5D-3L questionnaire is a generic, preference based health utility measure that assesses 5 health states (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and is used to build a composite of the patient's health status. The EQ-5D-3L was employed in this study to calculate health utilities for economic modeling, which ranged 0-1. The EQ-5D-3L also contained a visual analog scale (VAS) to assess the participant's overall health, which ranged from 0-100 with a higher score indicating a worse health status.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">445</enrollment>
  <condition>Lymphocytic Leukemia, Chronic</condition>
  <arm_group>
    <arm_group_label>Safety Run-in Obinutuzumab + Venetoclax</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised of 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obinutuzumab + Chlorambucil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obinutuzumab + Venetoclax</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chlorambucil</intervention_name>
    <description>Chlorambucil 0.5 milligrams per kilogram (mg/kg) orally at Day 1 and Day 15 at of each 28 day cycle for 12 cycles.</description>
    <arm_group_label>Obinutuzumab + Chlorambucil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Venetoclax</intervention_name>
    <description>Venetoclax, oral tablet: 20 mg daily during Cycle 1, Day 22-28; 50 mg daily during Cycle 2, Day 1-7; 100 mg daily during Cycle 2, Day 8-14; 200 mg daily during Cycle 2, Day 15-21; 400 mg daily during Cycle 2, Day 22-28 and on Day 1-28 for all subsequent cycles until the end of Cycle 12.</description>
    <arm_group_label>Obinutuzumab + Venetoclax</arm_group_label>
    <arm_group_label>Safety Run-in Obinutuzumab + Venetoclax</arm_group_label>
    <other_name>ABT-0199, GDC-0199</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Obinutuzumab</intervention_name>
    <description>Obinutuzumab, IV infusion: 100 mg or 1000 mg, depending on splitting rules, at Cycle 1, Day 1 (if 100 mg was received on Day 1, 900 mg will be administered on Cycle 1, Day 2); 1000 mg at Cycle 1, Day 8 and Day 15; 1000 mg at Day 1 for all subsequent cycles until the end of Cycle 6</description>
    <arm_group_label>Obinutuzumab + Chlorambucil</arm_group_label>
    <arm_group_label>Obinutuzumab + Venetoclax</arm_group_label>
    <arm_group_label>Safety Run-in Obinutuzumab + Venetoclax</arm_group_label>
    <other_name>GA-101; Gazyva</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documented previously untreated CLL according to the International Workshop on Chronic&#xD;
             Lymphocytic Leukemia (IWCLL) criteria&#xD;
&#xD;
          -  CLL requiring treatment according to IWCLL criteria&#xD;
&#xD;
          -  Total Cumulative Illness Rating Scale (CIRS score) greater than (&gt;) 6&#xD;
&#xD;
          -  Adequate marrow function independent of growth factor or transfusion support within 2&#xD;
             weeks of screening as per protocol, unless cytopenia is due to marrow involvement of&#xD;
             CLL&#xD;
&#xD;
          -  Adequate liver function&#xD;
&#xD;
          -  Life expectancy &gt; 6 months&#xD;
&#xD;
          -  Agreement to use highly effective contraceptive methods per protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Transformation of CLL to aggressive Non-Hodgkin's lymphoma (Richter's transformation&#xD;
             or pro-lymphocytic leukemia)&#xD;
&#xD;
          -  Known central nervous system involvement&#xD;
&#xD;
          -  Participants with a history of confirmed progressive multifocal leukoencephalopathy&#xD;
             (PML)&#xD;
&#xD;
          -  An individual organ/ system impairment score of 4 as assessed by the CIRS definition&#xD;
             limiting the ability to receive the treatment regimen of this trial with the exception&#xD;
             of eyes, ears, nose, throat organ system&#xD;
&#xD;
          -  Participants with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia&#xD;
&#xD;
          -  Inadequate renal function&#xD;
&#xD;
          -  History of prior malignancy, except for conditions as listed in the protocol if&#xD;
             participants have recovered from the acute side effects incurred as a result of&#xD;
             previous therapy&#xD;
&#xD;
          -  Use of investigational agents or concurrent anti-cancer treatment within the last 4&#xD;
             weeks of registration&#xD;
&#xD;
          -  Participants with active bacterial, viral, or fungal infection requiring systemic&#xD;
             treatment within the last two months prior to registration&#xD;
&#xD;
          -  History of severe allergic or anaphylactic reactions to humanized or murine monoclonal&#xD;
             antibodies or known sensitivity or allergy to murine products&#xD;
&#xD;
          -  Hypersensitivity to chlorambucil, obinutuzumab, or venetoclax or to any of the&#xD;
             excipients&#xD;
&#xD;
          -  Pregnant women and nursing mothers&#xD;
&#xD;
          -  Positive test results for chronic hepatitis B virus (HBV) infection (defined as&#xD;
             positive hepatitis B surface antigen [HBsAg] serology) or positive test result for&#xD;
             hepatitis C (hepatitis C virus [HCV] antibody serology testing)&#xD;
&#xD;
          -  Participants with known infection with human immunodeficiency virus (HIV) or human&#xD;
             T-cell leukemia virus-1 (HTLV-1)&#xD;
&#xD;
          -  Requires the use of warfarin, marcumar, or phenprocoumon&#xD;
&#xD;
          -  Received agents known to be strong and moderate Cytochrome P450 3A inhibitors or&#xD;
             inducers within 7 days prior to the first dose of study drug&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City of Hope</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Diego Pacific Hematology Assocates</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024-1375</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC San Diego Health System</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Banner MD Anderson Cancer Center</name>
      <address>
        <city>Greeley</city>
        <state>Colorado</state>
        <zip>85234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moffitt Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Winship Cancer Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ingalls Memorial Hospital</name>
      <address>
        <city>Harvey</city>
        <state>Illinois</state>
        <zip>60426</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Joe Arrington Cancer Center</name>
      <address>
        <city>Lubbock</city>
        <state>Texas</state>
        <zip>79410</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Italiano</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1181ACH</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liverpool Hospital</name>
      <address>
        <city>Liverpool</city>
        <state>New South Wales</state>
        <zip>2170</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tweed Hospital</name>
      <address>
        <city>Tweed Heads</city>
        <state>New South Wales</state>
        <zip>2485</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Townsville Hospital</name>
      <address>
        <city>Douglas</city>
        <state>Queensland</state>
        <zip>4814</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology</name>
      <address>
        <city>Woolloongabba</city>
        <state>Queensland</state>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital; Haematology Clinical Trials</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ashford Cancer Centre Research; Internal Medicine/Medical Oncology</name>
      <address>
        <city>Ashford</city>
        <state>South Australia</state>
        <zip>5035</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Box Hill Hospital</name>
      <address>
        <city>Box Hill</city>
        <state>Victoria</state>
        <zip>3128</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Northern Hospital</name>
      <address>
        <city>Epping</city>
        <state>Victoria</state>
        <zip>VIC 3076</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Medical Centre; Haematology</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie &amp; Onkologie</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie &amp; Hämostaseologie</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hanusch-Krankenhaus; Iii. Medizinische Abt.</name>
      <address>
        <city>Wien</city>
        <zip>1140</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilhelminenspital; I. Medizinische Abt.</name>
      <address>
        <city>Wien</city>
        <zip>1160</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital das Clinicas - UFRGS</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Ensino e Pesquisa Sao Lucas - IEP</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>01236-030</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Sírio-Libanês</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>01308-050</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital das Clinicas - FMUSP</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>05403-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Marcelina</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>08270-070</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT Dr Georgi Stranski; Hematology</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT &quot; Sveti Georgi&quot; Plovdiv - Clinic of Oncology and Hematology</name>
      <address>
        <city>Plovdiv</city>
        <zip>4002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Sv.Georgi Clnic of Hematology; Hematology</name>
      <address>
        <city>Plovdiv</city>
        <zip>4002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Multiprofile Hospital For Active Treatment &quot;Sveti Ivan Rilski&quot; EAD; clinical hematology</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT Hristo Botev; First Internal Department</name>
      <address>
        <city>Vratsa</city>
        <zip>3000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tom Baker Cancer Centre; Dept of Medicine</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth II Health Sciences Centre; Oncology</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 2Y9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jewish General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Center Zagreb; Haematology Department</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Merkur Clinic for Internal Medicine/ Hematology</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herlev Hospital</name>
      <address>
        <city>Herlev</city>
        <zip>2730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>København Ø</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sjællands Universitetshospital, Roskilde</name>
      <address>
        <city>Roskilde</city>
        <zip>4000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sygehus Lillebælt, Vejle</name>
      <address>
        <city>Vejle</city>
        <zip>7100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Estonia medical Centre; Hematology</name>
      <address>
        <city>Tallinn</city>
        <zip>13419</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tartu Uni Hospital; Hematology - Oncology Clinic</name>
      <address>
        <city>Tartu</city>
        <zip>51014</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Besançon - Hôpital Jean Minjoz</name>
      <address>
        <city>Besançon Cedex</city>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut d'Hématologie de Basse Normandie</name>
      <address>
        <city>Caen</city>
        <zip>14000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Estaing; Hematologie Clinique Adultes</name>
      <address>
        <city>Clermont Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Henri Mondor</name>
      <address>
        <city>Creteil</city>
        <zip>94000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Dijon - Hopital le Bocage</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Grenoble</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Jean Bernard</name>
      <address>
        <city>Le Mans</city>
        <zip>72015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Leon Berard; Departement Oncologie Medicale</name>
      <address>
        <city>Lyon</city>
        <zip>69373</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Eloi; Service d?Hématologie et Oncologie Clinique - Recherche Clinique</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Hotel Dieu Et Hme;Hopital De Jour</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)</name>
      <address>
        <city>Paris</city>
        <zip>75475</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Pontchaillou; Hematologie Clinique</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Henri Becquerel; Hematologie</name>
      <address>
        <city>Rouen</city>
        <zip>76038</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de Toulon Hôpital Sainte Musse</name>
      <address>
        <city>Toulon</city>
        <zip>83056</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy - Hematologie</name>
      <address>
        <city>Villejuif</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniklinik RWTH Aachen; Klinik IV; Klinik Hämatologie, Onkologie, Hämostaseologie und Stamm.</name>
      <address>
        <city>Aachen</city>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gesundheitszentrum St. Marien GmbH; Med. II, Hämatologie/Onkologie</name>
      <address>
        <city>Amberg</city>
        <zip>92224</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite - Campus Virchow-Klinikum</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum &quot;Carl Gustav Carus&quot;; Medizinische Klinik und Poliklinik I</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Essen; Klinik für Hämatologie</name>
      <address>
        <city>Essen</city>
        <zip>45122</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik Esslingen; Klinik für Allgemeine Innere Medizin, Onkologie/Haematologie</name>
      <address>
        <city>Esslingen</city>
        <zip>73730</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Frankfurt/Oder</name>
      <address>
        <city>Frankfurt/Oder</city>
        <zip>15236</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniklinikum Freiburg</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uni Göttingen, Georg-August-Universität; Klinik für Hämatologie und Medizinische Onkologie</name>
      <address>
        <city>Göttingen</city>
        <zip>37075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stiftung Kathol. Krankenhaus Marienhospital Herne Klinik Mitte</name>
      <address>
        <city>Herne</city>
        <zip>44625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxisklinik für Hämatologie und Onkologie Koblenz</name>
      <address>
        <city>Koblenz</city>
        <zip>56068</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Köln; Innere Medizin I; Onkologie, Hämatologie</name>
      <address>
        <city>Köln</city>
        <zip>50931</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tagesklinik Landshut; Hämatologie/Onkologie</name>
      <address>
        <city>Landshut</city>
        <zip>84028</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum rechts der Isar der Technischen Universität München</name>
      <address>
        <city>Munchen</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Schwäbisch Gmünd</name>
      <address>
        <city>Mutlangen</city>
        <zip>73557</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kliniken Maria Hilf GmbH; Innere Medizin I; Hämatologie und internistische Onkologie</name>
      <address>
        <city>Mönchengladbach</city>
        <zip>41063</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>München Klinik Schwabing; Klinik für Hämatologie, Onkologie, Immunologie</name>
      <address>
        <city>München</city>
        <zip>80804</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III</name>
      <address>
        <city>München</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gemeinschaftspraxis Dr. med. Holger Klaproth</name>
      <address>
        <city>Neunkirchen/Saar</city>
        <zip>66538</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brüderkrankenhaus St. Josef Paderborn</name>
      <address>
        <city>Paderborn</city>
        <zip>33098</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus Barmherzige Bruder Regensburg</name>
      <address>
        <city>Regensburg</city>
        <zip>93049</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marienhospital</name>
      <address>
        <city>Stuttgart</city>
        <zip>70199</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Robert-Bosch-Krankenhaus</name>
      <address>
        <city>Stuttgart</city>
        <zip>70376</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Tübingen</name>
      <address>
        <city>Tübingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universtitätsklinikum Ulm; Klinik für Innere Medizin III</name>
      <address>
        <city>Ulm</city>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinisches Versorgungszentrum Nuklearmedizin-Strahlentherapie-Onkologie</name>
      <address>
        <city>Weiden</city>
        <zip>92367</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcispedale S. Anna; Sezione Di Ematologia</name>
      <address>
        <city>Ferrara</city>
        <state>Emilia-Romagna</state>
        <zip>44100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedali Riuniti Papardo-Piemonte; Struttura Complessa Di Ematologia</name>
      <address>
        <city>Messina</city>
        <state>Lazio</state>
        <zip>98158</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uni Cattolica; Divisione Di Ematologia</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU Città della Salute e della Scienza di Torino - Presidio Le Molinette</name>
      <address>
        <city>Torino</city>
        <state>Lazio</state>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Raffaele</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Az. Osp. S. Maria; Dept. Di Oncologia Medica</name>
      <address>
        <city>Terni</city>
        <state>Umbria</state>
        <zip>05100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale dell' Angelo; U.O. Ematologia</name>
      <address>
        <city>Venezia Mestre</city>
        <state>Veneto</state>
        <zip>30174</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Culiacan</name>
      <address>
        <city>Culiacan</city>
        <state>Sinaloa</state>
        <zip>80230</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Canterbury Health Laboratories; Haematology</name>
      <address>
        <city>Christchurch</city>
        <zip>8011</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dunedin Hospital</name>
      <address>
        <city>Dunedin</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midcentral District Health Board</name>
      <address>
        <city>Palmerston North</city>
        <zip>4442</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellington Hospital</name>
      <address>
        <city>Wellington</city>
        <zip>6012</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersytecki Szpital Kliniczny w Bia?ymstoku, Klinika Hematologii z Pododdzia?em Chorob Naczyn</name>
      <address>
        <city>Bialystok</city>
        <zip>15-2</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samodzielny Public Zaklad</name>
      <address>
        <city>Chorzów</city>
        <zip>41-500</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewódzki Szpital Specjalistyczny im.Miko?ajaKopernika;KlinikaHematologiiUniwersytetuMedycznego</name>
      <address>
        <city>Lodz</city>
        <zip>9351</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewodzki Szpital Specjalistyczny im. J. Korczaka; Oddzia? Chorób Wewnetrznych/Hematologiczny</name>
      <address>
        <city>Slupsk</city>
        <zip>76-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroc?awiu; Klinika Hematologii</name>
      <address>
        <city>Wroclaw</city>
        <zip>5036</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundeni Clinical Inst. ; Hematology Dept</name>
      <address>
        <city>Bucharest</city>
        <zip>022328</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institutul Regional de Oncologie Iasi; Clinica de Hematologie</name>
      <address>
        <city>Iasi</city>
        <zip>700483</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie</name>
      <address>
        <city>Targu-mures</city>
        <zip>540136</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SBEI of HPE ?Bashkir State Medical University? of MoH RF</name>
      <address>
        <city>UFA</city>
        <state>Baskortostan</state>
        <zip>450000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moscow State Budgetary Healthcare Institution</name>
      <address>
        <city>Moscow</city>
        <state>Moskovskaja Oblast</state>
        <zip>123182</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Clinical Hospital N.A. Semashko; Hematology</name>
      <address>
        <city>Nizhny Novgorod</city>
        <state>Niznij Novgorod</state>
        <zip>603126</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rostov State Medical Uni ; Hematology</name>
      <address>
        <city>Rostov-na-donu</city>
        <state>Rostov</state>
        <zip>344022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Republican Clinical Oncologic Dispensary of Republic Of Tatarstan</name>
      <address>
        <city>Kazan</city>
        <state>Tatarstan</state>
        <zip>420029</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penza Regional Oncology Dispensary</name>
      <address>
        <city>Penza</city>
        <zip>440071</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical MSCh No1</name>
      <address>
        <city>Perm</city>
        <zip>614077</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Navarra</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Canarias;servicio de Hematologia</name>
      <address>
        <city>La Laguna</city>
        <state>Tenerife</state>
        <zip>38320</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital del Mar; Servicio de Hematologia</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebron; Servicio de Hematologia</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínic i Provincial; Servicio de Hematología y Oncología</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de la Princesa; Servicio de Hematologia</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Univ. 12 de Octubre; Servicio de Hematologia</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Salamanca;Servicio de Hematologia</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocio</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Hematología</name>
      <address>
        <city>Toledo</city>
        <zip>45004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Arnau de Vilanova (Valencia) Servicio de Hematologia</name>
      <address>
        <city>Valencia</city>
        <zip>46015</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inselspital Bern; Hämatologie und Hämatologisches Zentrallabor</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Luzerner Kantonsspital, Hämatologie</name>
      <address>
        <city>Luzern</city>
        <zip>6000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsspital Zürich Medizin Hämatologie; Klinik für Hämatologie</name>
      <address>
        <city>Zürich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Birmingham Heartlands Hospital</name>
      <address>
        <city>Birmingham</city>
        <zip>B9 5SS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Pilgrim Hospital</name>
      <address>
        <city>Boston,Lincolnshire</city>
        <zip>PE21 9QS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western General Hospital; Department of Haematology</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH4 2XU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lincoln County Hospital</name>
      <address>
        <city>Lincoln</city>
        <zip>LN2 5QY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Southampton NHS Foundation Trust</name>
      <address>
        <city>Southhampton</city>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Austria</country>
    <country>Brazil</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Croatia</country>
    <country>Denmark</country>
    <country>Estonia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Mexico</country>
    <country>New Zealand</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Egypt</country>
  </removed_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <results_first_submitted>August 15, 2019</results_first_submitted>
  <results_first_submitted_qc>September 10, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 1, 2019</results_first_posted>
  <last_update_submitted>June 22, 2023</last_update_submitted>
  <last_update_submitted_qc>June 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
    <mesh_term>Leukemia, Lymphocytic, Chronic, B-Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Venetoclax</mesh_term>
    <mesh_term>Obinutuzumab</mesh_term>
    <mesh_term>Chlorambucil</mesh_term>
  </intervention_browse>
  <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>February 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT02242942/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 8, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT02242942/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Obinutuzumab + Chlorambucil</title>
          <description>Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.</description>
        </group>
        <group group_id="P2">
          <title>Obinutuzumab + Venetoclax</title>
          <description>Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.</description>
        </group>
        <group group_id="P3">
          <title>Safety Run-in Obinutuzumab + Venetoclax</title>
          <description>Subjects received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised of 28 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="216"/>
                <participants group_id="P2" count="216"/>
                <participants group_id="P3" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="214"/>
                <participants group_id="P2" count="212"/>
                <participants group_id="P3" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="216"/>
                <participants group_id="P2" count="216"/>
                <participants group_id="P3" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>On-going in Study</title>
              <participants_list>
                <participants group_id="P1" count="190"/>
                <participants group_id="P2" count="186"/>
                <participants group_id="P3" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Obinutuzumab + Chlorambucil</title>
          <description>Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.</description>
        </group>
        <group group_id="B2">
          <title>Obinutuzumab + Venetoclax</title>
          <description>Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.</description>
        </group>
        <group group_id="B3">
          <title>Safety Run-in Obinutuzumab + Venetoclax</title>
          <description>Subjects received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised of 28 days.</description>
        </group>
        <group group_id="B4">
          <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="216"/>
            <count group_id="B2" value="216"/>
            <count group_id="B3" value="13"/>
            <count group_id="B4" value="445"/>
          </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="71.1" spread="8.0"/>
                    <measurement group_id="B2" value="71.1" spread="8.2"/>
                    <measurement group_id="B3" value="75.4" spread="7.8"/>
                    <measurement group_id="B4" value="71.1" spread="8.1"/>
                  </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="73"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="148"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="143"/>
                    <measurement group_id="B2" value="146"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="297"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="172"/>
                    <measurement group_id="B2" value="165"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="349"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Stated</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or other Pacific Islande</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="194"/>
                    <measurement group_id="B2" value="192"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="399"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Secondary</type>
        <title>Progression Free Survival (PFS) Based on Institutional Review Committee (IRC)-Assessments According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria</title>
        <description>PFS was determined according to IWCLL 2008 criteria and defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause. Disease progression was characterized by at least one of the following: 1) &gt;/= 50% increase in the absolute number of circulating lymphocytes to at least 5*10^9/L, 2) Appearance of new palpable lymph nodes (&gt; 15 mm in longest diameter) or any new extra-nodal lesion; 3) &gt;/= 50% increase in the longest diameter of any previous site of lymphadenopathy; 4) &gt;/= 50% increase in the enlargement of the liver and/or spleen; 5) Transformation to a more aggressive histology.</description>
        <time_frame>Baseline until disease progression or death up to approximately 3.75 years</time_frame>
        <population>Intent-to-Treat (ITT) population was defined as all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Obinutuzumab + Chlorambucil</title>
            <description>Participants received obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles comprised 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Obinutuzumab + Venetoclax</title>
            <description>Participants received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival (PFS) Based on Institutional Review Committee (IRC)-Assessments According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria</title>
          <description>PFS was determined according to IWCLL 2008 criteria and defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause. Disease progression was characterized by at least one of the following: 1) &gt;/= 50% increase in the absolute number of circulating lymphocytes to at least 5*10^9/L, 2) Appearance of new palpable lymph nodes (&gt; 15 mm in longest diameter) or any new extra-nodal lesion; 3) &gt;/= 50% increase in the longest diameter of any previous site of lymphadenopathy; 4) &gt;/= 50% increase in the enlargement of the liver and/or spleen; 5) Transformation to a more aggressive histology.</description>
          <population>Intent-to-Treat (ITT) population was defined as all randomized participants.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="216"/>
                <count group_id="O2" value="216"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="31.1" upper_limit="NA">Insufficient number of participants with events.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Insufficient number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.22</ci_lower_limit>
            <ci_upper_limit>0.51</ci_upper_limit>
            <estimate_desc>Hazard ratios were estimated by Cox regression model. Stratification factors: Binet and Geographic region.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Progression Free Survival (PFS) Based on Investigator Assessment According to IWCLL Criteria</title>
        <description>PFS was determined according to IWCLL 2008 criteria and defined as the time from randomization to the first occurrence of PD or death from any cause. Disease progression was characterized by at least one of the following: 1) &gt;/= 50% increase in the absolute number of circulating lymphocytes to at least 5*10^9/L, 2) Appearance of new palpable lymph nodes (&gt; 15 mm in longest diameter) or any new extra-nodal lesion; 3) &gt;/= 50% increase in the longest diameter of any previous site of lymphadenopathy; 4) &gt;/= 50% increase in the enlargement of the liver and/or spleen; 5) Transformation to a more aggressive histology.</description>
        <time_frame>Baseline until disease progression or death up to approximately 3.75 years</time_frame>
        <population>ITT population was defined as all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Obinutuzumab + Chlorambucil</title>
            <description>Participants received obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles comprised 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Obinutuzumab + Venetoclax</title>
            <description>Participants received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival (PFS) Based on Investigator Assessment According to IWCLL Criteria</title>
          <description>PFS was determined according to IWCLL 2008 criteria and defined as the time from randomization to the first occurrence of PD or death from any cause. Disease progression was characterized by at least one of the following: 1) &gt;/= 50% increase in the absolute number of circulating lymphocytes to at least 5*10^9/L, 2) Appearance of new palpable lymph nodes (&gt; 15 mm in longest diameter) or any new extra-nodal lesion; 3) &gt;/= 50% increase in the longest diameter of any previous site of lymphadenopathy; 4) &gt;/= 50% increase in the enlargement of the liver and/or spleen; 5) Transformation to a more aggressive histology.</description>
          <population>ITT population was defined as all randomized participants.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="216"/>
                <count group_id="O2" value="216"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="31.1" upper_limit="NA">Insufficient number of participants with events.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Insufficient number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.35</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.23</ci_lower_limit>
            <ci_upper_limit>0.53</ci_upper_limit>
            <estimate_desc>Hazard Ratios were estimated by Cox regression model. Stratification factors: Binet and Geographic region.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With an Overall Response (OR) at Completion of Treatment, as Determined by the Investigator According to IWCLL Criteria</title>
        <description>OR was defined as complete response (CR), CR with incomplete bone marrow recovery (CRi), or partial response (PR) according to IWCLL 2008 criteria. CR requires all of the following: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination and computed tomography (CT) scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils &gt;1.5*10^9/L, platelets &gt;100*10^9/L and hemoglobin &gt;110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri). PR: two of the following features for at least 2 months: &gt;/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, &gt;/=50% reduction in lymphadenopathy, &gt;/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils &gt;1.5*10^9/L, platelets &gt;100*10^9/L and hemoglobin &gt;110 g/L.</description>
        <time_frame>At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)</time_frame>
        <population>ITT population was defined as all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Obinutuzumab + Chlorambucil</title>
            <description>Participants received obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles comprised 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Obinutuzumab + Venetoclax</title>
            <description>Participants received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an Overall Response (OR) at Completion of Treatment, as Determined by the Investigator According to IWCLL Criteria</title>
          <description>OR was defined as complete response (CR), CR with incomplete bone marrow recovery (CRi), or partial response (PR) according to IWCLL 2008 criteria. CR requires all of the following: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination and computed tomography (CT) scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils &gt;1.5*10^9/L, platelets &gt;100*10^9/L and hemoglobin &gt;110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri). PR: two of the following features for at least 2 months: &gt;/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, &gt;/=50% reduction in lymphadenopathy, &gt;/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils &gt;1.5*10^9/L, platelets &gt;100*10^9/L and hemoglobin &gt;110 g/L.</description>
          <population>ITT population was defined as all randomized participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="216"/>
                <count group_id="O2" value="216"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.3" lower_limit="64.77" upper_limit="77.23"/>
                    <measurement group_id="O2" value="84.7" lower_limit="79.22" upper_limit="89.24"/>
                  </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>0.0007</p_value>
            <p_value_desc>P-value was assessed using Cochran-Mantel-Haenszel (CMH) test stratified by the IvRS randomization stratification factors.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Response Rates</param_type>
            <param_value>13.43</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.47</ci_lower_limit>
            <ci_upper_limit>21.38</ci_upper_limit>
            <estimate_desc>95% Confidence Interval (CI) for difference in rates were constructed using Anderson-Hauck method.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a Complete Response Rate (CRR) at the Completion of Treatment Assessment as Determined by the Investigator According to IWCLL Criteria</title>
        <description>CRR was defined as the rate of a clinical response of CR or CRi according to IWCLL 2008 criteria. CR requires all of the following: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination and CT scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils &gt;1.5*10^9/L, platelets &gt;100*10^9/L and hemoglobin &gt;110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri).</description>
        <time_frame>At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)</time_frame>
        <population>ITT population was defined as all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Obinutuzumab + Chlorambucil</title>
            <description>Participants received obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles comprised 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Obinutuzumab + Venetoclax</title>
            <description>Participants received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Complete Response Rate (CRR) at the Completion of Treatment Assessment as Determined by the Investigator According to IWCLL Criteria</title>
          <description>CRR was defined as the rate of a clinical response of CR or CRi according to IWCLL 2008 criteria. CR requires all of the following: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination and CT scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils &gt;1.5*10^9/L, platelets &gt;100*10^9/L and hemoglobin &gt;110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri).</description>
          <population>ITT population was defined as all randomized participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="216"/>
                <count group_id="O2" value="216"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.1" lower_limit="17.70" upper_limit="29.35"/>
                    <measurement group_id="O2" value="49.5" lower_limit="42.68" upper_limit="56.40"/>
                  </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;0.0001</p_value>
            <p_value_desc>P-value was assessed using CMH test stratified by the IvRS randomization stratification factors.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Response Rates</param_type>
            <param_value>26.39</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>17.41</ci_lower_limit>
            <ci_upper_limit>35.36</ci_upper_limit>
            <estimate_desc>95% CI for difference in rates were constructed using Anderson-Hauck method.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Minimal Residual Disease (MRD) Negativity in Peripheral Blood as Measured by Allele-Specific Oligonucleotide Polymerase Chain Reaction (ASO-PCR) at Completion of Treatment</title>
        <description>MRD negativity was defined as having &lt; 1 CLL cell per 10,000 leucocytes in peripheral blood.</description>
        <time_frame>At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)</time_frame>
        <population>ITT population was defined as all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Obinutuzumab + Chlorambucil</title>
            <description>Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Obinutuzumab + Venetoclax</title>
            <description>Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Minimal Residual Disease (MRD) Negativity in Peripheral Blood as Measured by Allele-Specific Oligonucleotide Polymerase Chain Reaction (ASO-PCR) at Completion of Treatment</title>
          <description>MRD negativity was defined as having &lt; 1 CLL cell per 10,000 leucocytes in peripheral blood.</description>
          <population>ITT population was defined as all randomized participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="216"/>
                <count group_id="O2" value="216"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.2" lower_limit="28.83" upper_limit="41.95"/>
                    <measurement group_id="O2" value="75.5" lower_limit="69.17" upper_limit="81.05"/>
                  </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;0.0001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in MRD Negative Rates</param_type>
            <param_value>40.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>31.45</ci_lower_limit>
            <ci_upper_limit>49.10</ci_upper_limit>
            <estimate_desc>95% CI for difference in rates were constructed using Anderson-Hauck method.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Treatment</title>
        <description>MRD negativity was defined as having &lt; 1 CLL cell per 10,000 leucocytes in bone marrow.</description>
        <time_frame>At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)</time_frame>
        <population>ITT population was defined as all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Obinutuzumab + Chlorambucil</title>
            <description>Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Obinutuzumab + Venetoclax</title>
            <description>Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Treatment</title>
          <description>MRD negativity was defined as having &lt; 1 CLL cell per 10,000 leucocytes in bone marrow.</description>
          <population>ITT population was defined as all randomized participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="216"/>
                <count group_id="O2" value="216"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.1" lower_limit="12.36" upper_limit="22.83"/>
                    <measurement group_id="O2" value="56.9" lower_limit="50.05" upper_limit="63.64"/>
                  </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;0.0001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in MRD Negative Rates</param_type>
            <param_value>39.81</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>31.27</ci_lower_limit>
            <ci_upper_limit>48.36</ci_upper_limit>
            <estimate_desc>95% CI for difference in rates were constructed using Anderson-Hauck method.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>OS was defined as the time between the date of randomization and the date of death due to any cause.</description>
        <time_frame>Baseline until death, up to approximately 10.75 years</time_frame>
        <posting_date>08/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With MRD Negativity in Peripheral Blood as Measured by ASO-PCR at Completion of Combination Treatment Assessment</title>
        <description>MRD negativity was defined as having &lt; 1 CLL cell per 10,000 leucocytes in peripheral blood.</description>
        <time_frame>Day 1 Cycle 9 or 3 months after last IV infusion, approximately 9 months</time_frame>
        <population>ITT population was defined as all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Obinutuzumab + Chlorambucil</title>
            <description>Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Obinutuzumab + Venetoclax</title>
            <description>Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With MRD Negativity in Peripheral Blood as Measured by ASO-PCR at Completion of Combination Treatment Assessment</title>
          <description>MRD negativity was defined as having &lt; 1 CLL cell per 10,000 leucocytes in peripheral blood.</description>
          <population>ITT population was defined as all randomized participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="216"/>
                <count group_id="O2" value="216"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.4" lower_limit="31.91" upper_limit="45.27"/>
                    <measurement group_id="O2" value="71.3" lower_limit="64.77" upper_limit="77.23"/>
                  </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;0.0001</p_value>
            <method>Chi-squared</method>
            <param_type>Difference in MRD Negative Rates</param_type>
            <param_value>32.87</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>23.76</ci_lower_limit>
            <ci_upper_limit>41.98</ci_upper_limit>
            <estimate_desc>95% CI for difference in rates were constructed using Anderson-Hauck method.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Combination Treatment Assessment</title>
        <description>MRD negativity was defined as having &lt; 1 CLL cell per 10,000 leucocytes in bone marrow.</description>
        <time_frame>Day 1 Cycle 9 or 3 months after last IV infusion at approximately 9 months</time_frame>
        <population>ITT population was defined as all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Obinutuzumab + Chlorambucil</title>
            <description>Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Obinutuzumab + Venetoclax</title>
            <description>Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Combination Treatment Assessment</title>
          <description>MRD negativity was defined as having &lt; 1 CLL cell per 10,000 leucocytes in bone marrow.</description>
          <population>ITT population was defined as all randomized participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="216"/>
                <count group_id="O2" value="216"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.0" lower_limit="8.79" upper_limit="18.19"/>
                    <measurement group_id="O2" value="51.4" lower_limit="44.51" upper_limit="58.23"/>
                  </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;0.0001</p_value>
            <method>Chi-squared</method>
            <param_type>Difference in MRD Negative Rates</param_type>
            <param_value>38.43</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>30.15</ci_lower_limit>
            <ci_upper_limit>46.71</ci_upper_limit>
            <estimate_desc>95% CI for difference in rates were constructed using Anderson-Hauck method.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With OR at Completion of Combination Treatment Response Assessment</title>
        <description>OR was defined as CR, CRi or PR according to IWCLL 2008 criteria. CR required all of the following: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils &gt;1.5*10^9/L, platelets &gt;100*10^9/L and hemoglobin &gt;110 g/L. PR: two of the following features for at least 2 months: &gt;/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, &gt;/=50% reduction in lymphadenopathy, &gt;/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils &gt;1.5*10^9/L, platelets &gt;100*10^9/L and hemoglobin &gt;110 g/L.</description>
        <time_frame>Day 1 Cycle 7 or 28 days after last IV infusion, approximately 6 months</time_frame>
        <population>ITT population was defined as all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Obinutuzumab + Chlorambucil</title>
            <description>Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Obinutuzumab + Venetoclax</title>
            <description>Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With OR at Completion of Combination Treatment Response Assessment</title>
          <description>OR was defined as CR, CRi or PR according to IWCLL 2008 criteria. CR required all of the following: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils &gt;1.5*10^9/L, platelets &gt;100*10^9/L and hemoglobin &gt;110 g/L. PR: two of the following features for at least 2 months: &gt;/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, &gt;/=50% reduction in lymphadenopathy, &gt;/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils &gt;1.5*10^9/L, platelets &gt;100*10^9/L and hemoglobin &gt;110 g/L.</description>
          <population>ITT population was defined as all randomized participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="216"/>
                <count group_id="O2" value="216"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.6" lower_limit="81.29" upper_limit="90.82"/>
                    <measurement group_id="O2" value="88.4" lower_limit="83.39" upper_limit="92.37"/>
                  </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>0.5612</p_value>
            <p_value_desc>P-value was assessed using Cochran-Mantel-Haenszel (CMH) test stratified by the IvRS randomization stratification factors.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Response Rates</param_type>
            <param_value>1.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.63</ci_lower_limit>
            <ci_upper_limit>8.33</ci_upper_limit>
            <estimate_desc>95% Confidence Interval (CI) for difference in rates were constructed using Anderson-Hauck method.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Objective Response (DOR)</title>
        <description>PD was defined as lymphadenopathy, &gt;=50% increase in liver or spleen size, &gt;=50% increase in lymphocyte count, transformation to a more aggressive histology or occurrence of cytopenia.</description>
        <time_frame>Time from the first occurrence of a documented objective response to the time of PD as determined by the investigator or death from any cause, up to approximately 10.75 years</time_frame>
        <posting_date>08/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants By Best Response Achieved (CR, CRi, PR, Stable Disease (SD), or PD)</title>
        <description>CR: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination and CT scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils &gt;1.5*10^9/L, platelets &gt;100*10^9/L and hemoglobin &gt;110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri). PR: any two for at least 2 months: &gt;/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, &gt;/=50% reduction in lymphadenopathy, &gt;/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils &gt;1.5*10^9/L, platelets &gt;100*10^9/L and hemoglobin &gt;110 g/L. PD: lymphadenopathy, &gt;=50% increase in liver or spleen size, &gt;=50% increase in lymphocyte count, transformation to a more aggressive histology or occurrence of cytopenia. SD: a non-response and used to characterize participants who did not achieve a CR or a PR, and who have not exhibited PD.</description>
        <time_frame>Baseline up to the completion of treatment assessment 3 months after treatment completion (up to approximately 15 months)</time_frame>
        <population>ITT population was defined as all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Obinutuzumab + Chlorambucil</title>
            <description>Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Obinutuzumab + Venetoclax</title>
            <description>Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants By Best Response Achieved (CR, CRi, PR, Stable Disease (SD), or PD)</title>
          <description>CR: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination and CT scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils &gt;1.5*10^9/L, platelets &gt;100*10^9/L and hemoglobin &gt;110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri). PR: any two for at least 2 months: &gt;/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, &gt;/=50% reduction in lymphadenopathy, &gt;/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils &gt;1.5*10^9/L, platelets &gt;100*10^9/L and hemoglobin &gt;110 g/L. PD: lymphadenopathy, &gt;=50% increase in liver or spleen size, &gt;=50% increase in lymphocyte count, transformation to a more aggressive histology or occurrence of cytopenia. SD: a non-response and used to characterize participants who did not achieve a CR or a PR, and who have not exhibited PD.</description>
          <population>ITT population was defined as all randomized participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="216"/>
                <count group_id="O2" value="216"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.0"/>
                    <measurement group_id="O2" value="70.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CRi</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6"/>
                    <measurement group_id="O2" value="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.2"/>
                    <measurement group_id="O2" value="13.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9"/>
                    <measurement group_id="O2" value="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5"/>
                    <measurement group_id="O2" value="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7169</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>P-value was assessed using CMH test stratified by the IvRS randomization stratification factors.</method_desc>
            <param_type>Difference in Response Rates</param_type>
            <param_value>0.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.66</ci_lower_limit>
            <ci_upper_limit>6.51</ci_upper_limit>
            <estimate_desc>95% CI for difference in rates were constructed using Anderson-Hauck method.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Event-Free Survival</title>
        <time_frame>Time between date of randomization and the date of disease progression/relapse on the basis of investigator-assessment, death, or start of a new anti-leukemic therapy, up to 10.75 years</time_frame>
        <posting_date>08/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Next Anti-Leukemic Treatment</title>
        <time_frame>Time between the date of randomization and the date of first intake of new anti-leukemic therapy, up to 10.75 years</time_frame>
        <posting_date>08/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events (AEs)</title>
        <description>An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs.</description>
        <time_frame>Up to approximately 10.75 years</time_frame>
        <posting_date>08/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With CD19 + /CD5+ B Cells or CD14+ Monocytes</title>
        <time_frame>Baseline up to approximately 10.75 years</time_frame>
        <posting_date>08/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Human-Anti-Human Antibodies</title>
        <time_frame>Baseline up to approximately 10.75 years</time_frame>
        <posting_date>08/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Recorded as Premature Study Withdrawals</title>
        <time_frame>Up to approximately 10.75 years</time_frame>
        <posting_date>08/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Concentrations of Venetoclax</title>
        <time_frame>Pre-venetoclax dose (0 hour) and 4 hours post- venetoclax dose on Day 1 Cycle 4</time_frame>
        <population>Analysis population consisted of subjects from whom one or more plasma samples were collected and who had received at least one 400 mg dose of venetoclax. Pre-dose and post-dose data may not come from the same participants. Total number analyzed is therefore higher than the number analyzed for each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Obinutuzumab + Venetoclax</title>
            <description>Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentrations of Venetoclax</title>
          <population>Analysis population consisted of subjects from whom one or more plasma samples were collected and who had received at least one 400 mg dose of venetoclax. Pre-dose and post-dose data may not come from the same participants. Total number analyzed is therefore higher than the number analyzed for each time point.</population>
          <units>μg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-Dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.578" spread="0.533"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours Post-Dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="142"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.21" spread="0.765"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Concentrations of Obinutuzumab</title>
        <time_frame>Pre-obinutuzumab infusion (0 hour) and end of obinutuzumab infusion on Day 1 Cycle 4</time_frame>
        <population>Analysis population consisted of subjects from whom one or more serum samples were collected and who had received at least one dose of obinutuzumab and one dose of 400 mg venetoclax. Pre-dose and post-dose data may not come from the same participants. Total number analyzed is therefore higher than the number analyzed for each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Obinutuzumab + Venetoclax</title>
            <description>Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Concentrations of Obinutuzumab</title>
          <population>Analysis population consisted of subjects from whom one or more serum samples were collected and who had received at least one dose of obinutuzumab and one dose of 400 mg venetoclax. Pre-dose and post-dose data may not come from the same participants. Total number analyzed is therefore higher than the number analyzed for each time point.</population>
          <units>μg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-Dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="258" spread="140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours Post-Dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="568" spread="187"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in M.D. Anderson Symptom Inventory-CLL (MDASI-CLL) Score</title>
        <description>The MDASI-CLL is a questionnaire of 25 items related to CLL specific symptoms that a participant may have experienced in the past 24 hours. Participants were asked to rate the severity of 13 symptoms called mean core symptom severity (i.e., pain, fatigue, nausea, disturbed sleep, distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sadness, vomiting, and numbness or tingling), 6 disease-specific symptoms called mean module symptom severity (night sweats, fevers and chills, lymph node swelling, diarrhea, easy bruising or bleeding, and constipation) and 6 mean interference on life questions (i.e., general activity, walking, work, mood, relations with other people, and enjoyment of life) on a scale from 0 to 10 with 0 indicating that the symptom is &quot;not present&quot; or &quot;did not interfere&quot; with the participant's activities and 10 indicating &quot;as bad as you can imagine&quot; or &quot;interfered completely&quot;. Scores were averaged (range 0 to 10) for each of three parts.</description>
        <time_frame>Baseline up to approximately 10.75 years</time_frame>
        <posting_date>08/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQC30)</title>
        <description>The EORTC QLQ-C30 is a validated and reliable self-report measure consisting of 30 questions incorporated into five functional scales (physical, role, cognitive, emotional, and social scales), three symptom scales (fatigue, pain, nausea, and vomiting scales), and a global health status/global quality-of-life scale. The remaining single items (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) assess the additional symptoms experienced by patients with cancer and the perceived financial burden of treatment. The 28 function and symptom items were scored on a 4-point scale that ranged from &quot;not at all&quot; to &quot;very much,&quot; and the 2 global health status/global quality-of-life items were scored on a 7-point scale that ranged from &quot;very poor&quot; to &quot;excellent.&quot; Raw average scale scores were linearly transformed to range 0-100 with higher scores indicating higher response levels (i.e., higher functioning, higher symptom severity).</description>
        <time_frame>Baseline up to approximately 10.75 years</time_frame>
        <posting_date>08/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D-3L)</title>
        <description>The EQ-5D-3L questionnaire is a generic, preference based health utility measure that assesses 5 health states (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and is used to build a composite of the patient's health status. The EQ-5D-3L was employed in this study to calculate health utilities for economic modeling, which ranged 0-1. The EQ-5D-3L also contained a visual analog scale (VAS) to assess the participant's overall health, which ranged from 0-100 with a higher score indicating a worse health status.</description>
        <time_frame>Baseline up to approximately 10.75 years</time_frame>
        <posting_date>08/2026</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All AEs from first dose until 28 days after the last dose up to 1 year. Grade 3-4 AEs: for 6 months after last dose (up to 1.5 years). Major infections (Grade 3-4): for 2 years after the last dose (up to 3 years) irrespective of causality unless disease progressed and participant received leukemic treatment. Before disease progression, SAEs were reported during follow-up (up to 3.75 years). After disease progression, only related SAEs and second primary malignancies were reported.</time_frame>
      <desc>All-cause mortality was based on the ITT population defined as all randomized participants. Reporting of serious and non-serious adverse events was based on the safety population defined as all participants who received at least one dose of any study medication (i.e., obinutuzumab, venetoclax, or chlorambucil).</desc>
      <group_list>
        <group group_id="E1">
          <title>Obinutuzumab + Chlorambucil</title>
          <description>Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.</description>
        </group>
        <group group_id="E2">
          <title>Obinutuzumab + Venetoclax</title>
          <description>Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.</description>
        </group>
        <group group_id="E3">
          <title>Safety Run-in Obinutuzumab + Venetoclax</title>
          <description>Subjects received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised of 28 days.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA, version 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="17" subjects_at_risk="216"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="216"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="90" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="104" subjects_at_risk="212"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="13"/>
              </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="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Autoimmune haemolytic anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Coombs negative haemolytic anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Disseminated intravascular coagulation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="214"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="212"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Immune thrombocytopenic purpura</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Splenic infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Splenomegaly</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="214"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Mitral valve incompetence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Ventricular fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Gilbert's syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </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="214"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Amaurosis fugax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Eye inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Keratitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Faecaloma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Gastric ulcer perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Adverse drug reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Device related thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="214"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="212"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Bronchopulmonary aspergillosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Candida infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Cholecystitis infective</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Chronic sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Eczema infected</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Endocarditis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Gastrointestinal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hepatitis E</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Infectious pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Infective exacerbation of chronic obstructive airways disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Listeriosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Muscle abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Neutropenic infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Ophthalmic herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="11" subjects_affected="9" subjects_at_risk="214"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pneumonia fungal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pneumonia haemophilus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pneumonia respiratory syncytial viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pseudomembranous colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="212"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Sinusitis aspergillus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Soft tissue infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Varicella zoster virus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Wound infection fungal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Chillblains</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Clavicle fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="214"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pelvic fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Subcutaneous haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Thoracic vertebral fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Transfusion reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Traumatic haemothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Vasoplegia syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Wound evisceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Blood urea increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Prothrombin time prolonged</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </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="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Tumour lysis syndrome</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Spondylitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acute myeloid leukaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Anal squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Bladder cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Bladder cancer recurrent</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Bladder neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Invasive breast carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Invasive ductal breast carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma stage IV</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Malignant melanoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Metastatic malignant melanoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Myelodysplastic syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Penile cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Prostate cancer metastatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Salivary gland adenoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Sarcoma of skin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Skin squamous cell carcinoma metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="214"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>T-cell lymphoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Cerebral ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Generalised tonic-clonic seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Radiculopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Vertebrobasilar insufficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </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="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Cystocele</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute pulmonary oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Bronchitis chronic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Bronchopneumopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" events="10" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Lung disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Aortic valve replacement</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Medical device removal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis superficial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA, version 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="205" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="193" subjects_at_risk="212"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="13"/>
              </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="55" subjects_affected="39" subjects_at_risk="214"/>
                <counts group_id="E2" events="53" subjects_affected="33" subjects_at_risk="212"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="19" subjects_affected="13" subjects_at_risk="214"/>
                <counts group_id="E2" events="23" subjects_affected="12" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="294" subjects_affected="122" subjects_at_risk="214"/>
                <counts group_id="E2" events="370" subjects_affected="121" subjects_at_risk="212"/>
                <counts group_id="E3" events="12" subjects_affected="8" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="76" subjects_affected="49" subjects_at_risk="214"/>
                <counts group_id="E2" events="86" subjects_affected="49" subjects_at_risk="212"/>
                <counts group_id="E3" events="5" subjects_affected="2" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Ventricular extrasystoles</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Excessive cerumen production</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="214"/>
                <counts group_id="E2" events="15" subjects_affected="11" subjects_at_risk="212"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="214"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="23" subjects_affected="19" subjects_at_risk="214"/>
                <counts group_id="E2" events="32" subjects_affected="28" subjects_at_risk="212"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="42" subjects_affected="32" subjects_at_risk="214"/>
                <counts group_id="E2" events="99" subjects_affected="59" subjects_at_risk="212"/>
                <counts group_id="E3" events="8" subjects_affected="5" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="214"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Epigastric discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="62" subjects_affected="46" subjects_at_risk="214"/>
                <counts group_id="E2" events="61" subjects_affected="40" subjects_at_risk="212"/>
                <counts group_id="E3" events="7" subjects_affected="4" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="22" subjects_affected="18" subjects_at_risk="214"/>
                <counts group_id="E2" events="27" subjects_affected="21" subjects_at_risk="212"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Adverse drug reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="20" subjects_affected="17" subjects_at_risk="214"/>
                <counts group_id="E2" events="20" subjects_affected="14" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="13" subjects_affected="10" subjects_at_risk="214"/>
                <counts group_id="E2" events="14" subjects_affected="12" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Extravasation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="36" subjects_affected="29" subjects_at_risk="214"/>
                <counts group_id="E2" events="40" subjects_affected="32" subjects_at_risk="212"/>
                <counts group_id="E3" events="6" subjects_affected="3" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="214"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="214"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="18" subjects_affected="16" subjects_at_risk="214"/>
                <counts group_id="E2" events="20" subjects_affected="17" subjects_at_risk="212"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="28" subjects_affected="26" subjects_at_risk="214"/>
                <counts group_id="E2" events="53" subjects_affected="40" subjects_at_risk="212"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Sensation of foreign body</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="214"/>
                <counts group_id="E2" events="14" subjects_affected="11" subjects_at_risk="212"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Eye infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="214"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="214"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="16" subjects_affected="14" subjects_at_risk="214"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="214"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="212"/>
                <counts group_id="E3" events="4" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="214"/>
                <counts group_id="E2" events="9" subjects_affected="6" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="214"/>
                <counts group_id="E2" events="14" subjects_affected="10" subjects_at_risk="212"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="214"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="214"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="17" subjects_affected="15" subjects_at_risk="214"/>
                <counts group_id="E2" events="19" subjects_affected="16" subjects_at_risk="212"/>
                <counts group_id="E3" events="4" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="214"/>
                <counts group_id="E2" events="13" subjects_affected="10" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Viral skin infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Eye contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="11" subjects_affected="8" subjects_at_risk="214"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" events="131" subjects_affected="103" subjects_at_risk="214"/>
                <counts group_id="E2" events="122" subjects_affected="89" subjects_at_risk="212"/>
                <counts group_id="E3" events="10" subjects_affected="9" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="15" subjects_affected="13" subjects_at_risk="214"/>
                <counts group_id="E2" events="15" subjects_affected="11" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="20" subjects_affected="17" subjects_at_risk="214"/>
                <counts group_id="E2" events="14" subjects_affected="12" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Blood albumin decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="214"/>
                <counts group_id="E2" events="9" subjects_affected="7" subjects_at_risk="212"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Blood magnesium decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Blood phosphorus increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="32" subjects_affected="11" subjects_at_risk="214"/>
                <counts group_id="E2" events="27" subjects_affected="10" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Procalcitonin increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Protein total decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="214"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </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="8" subjects_affected="6" subjects_at_risk="214"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="214"/>
                <counts group_id="E2" events="16" subjects_affected="14" subjects_at_risk="212"/>
                <counts group_id="E3" events="4" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="214"/>
                <counts group_id="E2" events="13" subjects_affected="4" subjects_at_risk="212"/>
                <counts group_id="E3" events="7" subjects_affected="5" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hyperphosphataemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="214"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Tumour lysis syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </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="23" subjects_affected="18" subjects_at_risk="214"/>
                <counts group_id="E2" events="19" subjects_affected="16" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="21" subjects_affected="20" subjects_at_risk="214"/>
                <counts group_id="E2" events="24" subjects_affected="21" subjects_at_risk="212"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="214"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="214"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="212"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="14" subjects_affected="13" subjects_at_risk="214"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="214"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Benign breast neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Seborrhoeic keratosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Skin papilloma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="20" subjects_affected="17" subjects_at_risk="214"/>
                <counts group_id="E2" events="18" subjects_affected="16" subjects_at_risk="212"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="24" subjects_affected="21" subjects_at_risk="214"/>
                <counts group_id="E2" events="29" subjects_affected="23" subjects_at_risk="212"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="214"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="212"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="214"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </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="27" subjects_affected="24" subjects_at_risk="214"/>
                <counts group_id="E2" events="37" subjects_affected="33" subjects_at_risk="212"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="214"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="212"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="214"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pharyngeal paraesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="214"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="212"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="214"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="214"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="212"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="214"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="214"/>
                <counts group_id="E2" events="20" subjects_affected="18" subjects_at_risk="212"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="214"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="212"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="214"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="214"/>
                <counts group_id="E2" events="17" subjects_affected="12" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="214"/>
                <counts group_id="E2" events="15" subjects_affected="11" subjects_at_risk="212"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Communications</name_or_title>
      <organization>Hoffmann-La Roche</organization>
      <phone>800 821-8590</phone>
      <email>genentech@druginfo.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/NCT02242942
org study id: BO25323
secondary id: 2014-001810-24
secondary id: CLL14
nct id: NCT02242942
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
This open-label, multicenter, randomized Phase III study is designed to compare the efficacy
      and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab +
      chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical
      conditions. The time on study treatment was approximately one year and the follow-up period
      will be up to 9 years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression Free Survival (PFS) Based on Investigator Assessment According to IWCLL Criteria
time frame: Baseline until disease progression or death up to approximately 3.75 years
description: PFS was determined according to IWCLL 2008 criteria and defined as the time from randomization to the first occurrence of PD or death from any cause. Disease progression was characterized by at least one of the following: 1) >/= 50% increase in the absolute number of circulating lymphocytes to at least 5*10^9/L, 2) Appearance of new palpable lymph nodes (> 15 mm in longest diameter) or any new extra-nodal lesion; 3) >/= 50% increase in the longest diameter of any previous site of lymphadenopathy; 4) >/= 50% increase in the enlargement of the liver and/or spleen; 5) Transformation to a more aggressive histology.
measure: Progression Free Survival (PFS) Based on Institutional Review Committee (IRC)-Assessments According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria
time frame: Baseline until disease progression or death up to approximately 3.75 years
description: PFS was determined according to IWCLL 2008 criteria and defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause. Disease progression was characterized by at least one of the following: 1) >/= 50% increase in the absolute number of circulating lymphocytes to at least 5*10^9/L, 2) Appearance of new palpable lymph nodes (> 15 mm in longest diameter) or any new extra-nodal lesion; 3) >/= 50% increase in the longest diameter of any previous site of lymphadenopathy; 4) >/= 50% increase in the enlargement of the liver and/or spleen; 5) Transformation to a more aggressive histology.
measure: Percentage of Participants With an Overall Response (OR) at Completion of Treatment, as Determined by the Investigator According to IWCLL Criteria
time frame: At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)
description: OR was defined as complete response (CR), CR with incomplete bone marrow recovery (CRi), or partial response (PR) according to IWCLL 2008 criteria. CR requires all of the following: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination and computed tomography (CT) scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri). PR: two of the following features for at least 2 months: >/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, >/=50% reduction in lymphadenopathy, >/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L.
measure: Percentage of Participants With a Complete Response Rate (CRR) at the Completion of Treatment Assessment as Determined by the Investigator According to IWCLL Criteria
time frame: At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)
description: CRR was defined as the rate of a clinical response of CR or CRi according to IWCLL 2008 criteria. CR requires all of the following: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination and CT scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri).
measure: Percentage of Participants With Minimal Residual Disease (MRD) Negativity in Peripheral Blood as Measured by Allele-Specific Oligonucleotide Polymerase Chain Reaction (ASO-PCR) at Completion of Treatment
time frame: At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)
description: MRD negativity was defined as having < 1 CLL cell per 10,000 leucocytes in peripheral blood.
measure: Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Treatment
time frame: At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)
description: MRD negativity was defined as having < 1 CLL cell per 10,000 leucocytes in bone marrow.
measure: Overall Survival (OS)
time frame: Baseline until death, up to approximately 10.75 years
description: OS was defined as the time between the date of randomization and the date of death due to any cause.
measure: Percentage of Participants With MRD Negativity in Peripheral Blood as Measured by ASO-PCR at Completion of Combination Treatment Assessment
time frame: Day 1 Cycle 9 or 3 months after last IV infusion, approximately 9 months
description: MRD negativity was defined as having < 1 CLL cell per 10,000 leucocytes in peripheral blood.
measure: Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Combination Treatment Assessment
time frame: Day 1 Cycle 9 or 3 months after last IV infusion at approximately 9 months
description: MRD negativity was defined as having < 1 CLL cell per 10,000 leucocytes in bone marrow.
measure: Percentage of Participants With OR at Completion of Combination Treatment Response Assessment
time frame: Day 1 Cycle 7 or 28 days after last IV infusion, approximately 6 months
description: OR was defined as CR, CRi or PR according to IWCLL 2008 criteria. CR required all of the following: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L. PR: two of the following features for at least 2 months: >/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, >/=50% reduction in lymphadenopathy, >/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L.
measure: Duration of Objective Response (DOR)
time frame: Time from the first occurrence of a documented objective response to the time of PD as determined by the investigator or death from any cause, up to approximately 10.75 years
description: PD was defined as lymphadenopathy, >=50% increase in liver or spleen size, >=50% increase in lymphocyte count, transformation to a more aggressive histology or occurrence of cytopenia.
measure: Percentage of Participants By Best Response Achieved (CR, CRi, PR, Stable Disease (SD), or PD)
time frame: Baseline up to the completion of treatment assessment 3 months after treatment completion (up to approximately 15 months)
description: CR: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination and CT scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri). PR: any two for at least 2 months: >/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, >/=50% reduction in lymphadenopathy, >/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L. PD: lymphadenopathy, >=50% increase in liver or spleen size, >=50% increase in lymphocyte count, transformation to a more aggressive histology or occurrence of cytopenia. SD: a non-response and used to characterize participants who did not achieve a CR or a PR, and who have not exhibited PD.
measure: Event-Free Survival
time frame: Time between date of randomization and the date of disease progression/relapse on the basis of investigator-assessment, death, or start of a new anti-leukemic therapy, up to 10.75 years
measure: Time to Next Anti-Leukemic Treatment
time frame: Time between the date of randomization and the date of first intake of new anti-leukemic therapy, up to 10.75 years
measure: Number of Participants With Adverse Events (AEs)
time frame: Up to approximately 10.75 years
description: An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs.
measure: Percentage of Participants With CD19 + /CD5+ B Cells or CD14+ Monocytes
time frame: Baseline up to approximately 10.75 years
measure: Percentage of Participants With Human-Anti-Human Antibodies
time frame: Baseline up to approximately 10.75 years
measure: Percentage of Participants Recorded as Premature Study Withdrawals
time frame: Up to approximately 10.75 years
measure: Plasma Concentrations of Venetoclax
time frame: Pre-venetoclax dose (0 hour) and 4 hours post- venetoclax dose on Day 1 Cycle 4
measure: Serum Concentrations of Obinutuzumab
time frame: Pre-obinutuzumab infusion (0 hour) and end of obinutuzumab infusion on Day 1 Cycle 4
measure: Change From Baseline in M.D. Anderson Symptom Inventory-CLL (MDASI-CLL) Score
time frame: Baseline up to approximately 10.75 years
description: The MDASI-CLL is a questionnaire of 25 items related to CLL specific symptoms that a participant may have experienced in the past 24 hours. Participants were asked to rate the severity of 13 symptoms called mean core symptom severity (i.e., pain, fatigue, nausea, disturbed sleep, distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sadness, vomiting, and numbness or tingling), 6 disease-specific symptoms called mean module symptom severity (night sweats, fevers and chills, lymph node swelling, diarrhea, easy bruising or bleeding, and constipation) and 6 mean interference on life questions (i.e., general activity, walking, work, mood, relations with other people, and enjoyment of life) on a scale from 0 to 10 with 0 indicating that the symptom is "not present" or "did not interfere" with the participant's activities and 10 indicating "as bad as you can imagine" or "interfered completely". Scores were averaged (range 0 to 10) for each of three parts.
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQC30)
time frame: Baseline up to approximately 10.75 years
description: The EORTC QLQ-C30 is a validated and reliable self-report measure consisting of 30 questions incorporated into five functional scales (physical, role, cognitive, emotional, and social scales), three symptom scales (fatigue, pain, nausea, and vomiting scales), and a global health status/global quality-of-life scale. The remaining single items (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) assess the additional symptoms experienced by patients with cancer and the perceived financial burden of treatment. The 28 function and symptom items were scored on a 4-point scale that ranged from "not at all" to "very much," and the 2 global health status/global quality-of-life items were scored on a 7-point scale that ranged from "very poor" to "excellent." Raw average scale scores were linearly transformed to range 0-100 with higher scores indicating higher response levels (i.e., higher functioning, higher symptom severity).
measure: Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D-3L)
time frame: Baseline up to approximately 10.75 years
description: The EQ-5D-3L questionnaire is a generic, preference based health utility measure that assesses 5 health states (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and is used to build a composite of the patient's health status. The EQ-5D-3L was employed in this study to calculate health utilities for economic modeling, which ranged 0-1. The EQ-5D-3L also contained a visual analog scale (VAS) to assess the participant's overall health, which ranged from 0-100 with a higher score indicating a worse health status.
arm group label: Safety Run-in Obinutuzumab + Venetoclax
arm group type: Experimental
description: Subjects received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised of 28 days.
arm group label: Obinutuzumab + Chlorambucil
arm group type: Experimental
description: Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.
arm group label: Obinutuzumab + Venetoclax
arm group type: Experimental
description: Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.
intervention type: Drug
intervention name: Chlorambucil
description: Chlorambucil 0.5 milligrams per kilogram (mg/kg) orally at Day 1 and Day 15 at of each 28 day cycle for 12 cycles.
arm group label: Obinutuzumab + Chlorambucil
intervention type: Drug
intervention name: Venetoclax
description: Venetoclax, oral tablet: 20 mg daily during Cycle 1, Day 22-28; 50 mg daily during Cycle 2, Day 1-7; 100 mg daily during Cycle 2, Day 8-14; 200 mg daily during Cycle 2, Day 15-21; 400 mg daily during Cycle 2, Day 22-28 and on Day 1-28 for all subsequent cycles until the end of Cycle 12.
arm group label: Obinutuzumab + Venetoclax
arm group label: Safety Run-in Obinutuzumab + Venetoclax
other name: ABT-0199, GDC-0199
intervention type: Drug
intervention name: Obinutuzumab
description: Obinutuzumab, IV infusion: 100 mg or 1000 mg, depending on splitting rules, at Cycle 1, Day 1 (if 100 mg was received on Day 1, 900 mg will be administered on Cycle 1, Day 2); 1000 mg at Cycle 1, Day 8 and Day 15; 1000 mg at Day 1 for all subsequent cycles until the end of Cycle 6
arm group label: Obinutuzumab + Chlorambucil
arm group label: Obinutuzumab + Venetoclax
arm group label: Safety Run-in Obinutuzumab + Venetoclax
other name: GA-101; Gazyva
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Argentina
country: Australia
country: Austria
country: Brazil
country: Bulgaria
country: Canada
country: Croatia
country: Denmark
country: Estonia
country: France
country: Germany
country: Italy
country: Mexico
country: New Zealand
country: Poland
country: Romania
country: Russian Federation
country: Spain
country: Switzerland
country: United Kingdom
country: United States
country: Egypt
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Lymphoid
mesh term: Leukemia, Lymphocytic, Chronic, B-Cell
mesh term: Venetoclax
mesh term: Obinutuzumab
mesh term: Chlorambucil
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 