<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT02187861</url>
  </required_header>
  <id_info>
    <org_study_id>BO29337</org_study_id>
    <secondary_id>2014-000576-26</secondary_id>
    <nct_id>NCT02187861</nct_id>
  </id_info>
  <brief_title>A Study Evaluating the Safety and Efficacy of Venetoclax (GDC-0199) Plus Bendamustine + Rituximab (BR) in Comparison With BR or Venetoclax Plus Rituximab in Participants With Relapsed and Refractory Follicular Non-Hodgkin's Lymphoma (fNHL)</brief_title>
  <official_title>A Phase II, Open-Label Study Evaluating the Safety and Efficacy of GDC-0199 (ABT-199) Plus Bendamustine Plus Rituximab (BR) in Comparison With BR Alone or GDC-0199 Plus Rituximab (R) in Patients With Relapsed and Refractory Follicular Non-Hodgkin's Lymphoma</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>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This open-label, international, multicenter study will investigate the safety and efficacy of&#xD;
      venetoclax (GDC-0199) in combination with bendamustine plus rituximab (venetoclax + BR)&#xD;
      compared with BR alone in participants with relapsed and refractory fNHL, comparing two&#xD;
      chemotherapy-containing regimens (Chemotherapy-Containing Cohort). In addition, an&#xD;
      exploratory analysis of the safety and efficacy of venetoclax in combination with rituximab&#xD;
      (venetoclax + rituximab), a chemotherapy-free regimen, will be performed (Chemotherapy-Free&#xD;
      Cohort). Assignment to the Chemotherapy-Containing or Chemotherapy-Free Cohort will be&#xD;
      decided at the discretion of the Investigator, unless one of the cohorts is not open to&#xD;
      enrollment; in which case, participants may be enrolled only to the open cohort. The first 6&#xD;
      participants enrolled in the Chemotherapy-Containing Cohort (or more if required) will&#xD;
      comprise the Safety Run-In group for Treatment Arm B, dosing venetoclax at 600 milligrams&#xD;
      (mg) in combination with BR. Once a dose has been chosen from the Safety Run-In Period,&#xD;
      randomization to the two treatment arms of the Chemotherapy-Containing Cohort (Arms B and C)&#xD;
      will begin.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2014</start_date>
  <completion_date type="Actual">March 16, 2018</completion_date>
  <primary_completion_date type="Actual">September 27, 2016</primary_completion_date>
  <phase>Phase 2</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>Percentage of Participants With Complete Metabolic Response (CMR) According to Independent Review Committee (IRC) as Per Lugano Classification, Using Positron Emission Tomography (PET) Scan at Primary Response Assessment (PRA)</measure>
    <time_frame>6-8 weeks after Cycle 6 Day 1 (PRA) (Cycle length = 28 days)</time_frame>
    <description>CMR: a score 1 (no uptake above background), 2 (uptake less than or equal to [&lt;=] mediastinum), or 3 (uptake less than [&lt;] mediastinum but &lt;=liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites with no new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With CMR According to Investigator as Per Lugano Classification, Using PET Scan at PRA</measure>
    <time_frame>4-10 weeks after Cycle 6 Day 1 (Cycle length = 28 days)</time_frame>
    <description>CMR: a score 1 (no uptake above background), 2 (uptake &lt;=mediastinum), or 3 (&lt;mediastinum but &lt;=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With CMR According to IRC as Per Lugano Classification, Using PET Scan at Year 1</measure>
    <time_frame>48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)</time_frame>
    <description>CMR: a score 1 (no uptake above background), 2 (uptake &lt;=mediastinum), or 3 (uptake &lt;mediastinum but &lt;=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With CMR According to Investigator as Per Lugano Classification, Using PET Scan at Year 1</measure>
    <time_frame>48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)</time_frame>
    <description>CMR: a score 1 (no uptake above background), 2 (uptake &lt;=mediastinum), or 3 (&lt;mediastinum but &lt;=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Complete Response (CR) According to IRC as Per Lugano Classification, Using Computed Tomography (CT) Scan</measure>
    <time_frame>6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)</time_frame>
    <description>CR: defined as reduction of longest transverse diameter of lesion (LDi) of target nodes/nodal masses to &lt;=1.5 centimeters (cm), and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/immunohistochemistry (IHC)-negative bone marrow morphology. Assessment was performed by an IRC according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With CR According to Investigator as Per Lugano Classification, Using CT Scan</measure>
    <time_frame>4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)</time_frame>
    <description>CR: defined as reduction of LDi of target nodes/nodal masses to &lt;=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. Assessment was performed by Investigator according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Objective Response (OR) According to IRC as Per Lugano Classification, Using PET Scan</measure>
    <time_frame>6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)</time_frame>
    <description>OR was defined as CMR or Partial Metabolic Response (PMR). CMR: a score 1 (no uptake above background), 2 (uptake &lt;=mediastinum), or 3 (&lt;mediastinum but &lt;=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. PMR: a score 4 (uptake moderately greater than [&gt;] liver) or 5 (uptake markedly &gt;liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using PET Scan</measure>
    <time_frame>4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)</time_frame>
    <description>OR was defined as CMR or PMR. CMR: a score 1 (no uptake above background), 2 (uptake &lt;=mediastinum), or 3 (&lt;mediastinum but &lt;=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. PMR: a score 4 (uptake moderately &gt;liver) or 5 (uptake markedly &gt;liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With OR According to IRC as Per Lugano Classification, Using CT Scan</measure>
    <time_frame>6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)</time_frame>
    <description>OR was defined as CR or Partial Response (PR). CR: reduction of LDi of target nodes/nodal masses to &lt;=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. PR: greater than or equal to (&gt;=) 50 percent (%) decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen at least &gt;50% beyond normal; and no new lesions. Assessment was performed by an IRC according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using CT Scan</measure>
    <time_frame>4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)</time_frame>
    <description>OR was defined as CR or PR. CR: reduction of LDi of target nodes/nodal masses to &lt;=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. PR: &gt;=50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen at least &gt;50% beyond normal; and no new lesions. Assessment was performed by Investigator according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using PET or CT Scan</measure>
    <time_frame>Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years)</time_frame>
    <description>OR was defined as CMR/CR or PMR/PR. CMR, CR, PMR, and PR have been defined in previous endpoints, and are not repeated here due to space constraint. Assessment was performed by Investigator according to Lugano classification using PET scan or CT scan (if PET is missing).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR) According to Investigator as Per Lugano Classification, Using PET or CT Scan</measure>
    <time_frame>From CMR or PMR until disease progression or death due to any cause (assessed up to approximately 2.5 years)</time_frame>
    <description>DOR was defined as time from CMR/CR or PMR/PR until progressive disease (PD) or death due to any cause. CMR, CR, PMR, and PR have been defined in previous endpoints, and are not repeated here due to space constraint. PD: a score 4 (uptake moderately &gt;liver) or 5 (uptake markedly &gt;liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan or CT scan (if PET is missing). DOR was calculated using Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Disease Progression (According to Investigator as Per Lugano Classification, Using PET or CT Scan) or Death</measure>
    <time_frame>Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years)</time_frame>
    <description>PD: a score 4 (uptake moderately &gt;liver) or 5 (uptake markedly &gt;liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS) According to Investigator as Per Lugano Classification, Using PET or CT Scan</measure>
    <time_frame>Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years)</time_frame>
    <description>PFS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) until the date of disease progression, or death due to any cause. PD: a score 4 (uptake moderately &gt;liver) or 5 (uptake markedly &gt;liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan. PFS was calculated using Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Disease Progression (According to Investigator as Per Lugano Classification, Using PET or CT Scan), Death, or Start of a New Anti-lymphoma Therapy</measure>
    <time_frame>Baseline until disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first (assessed up to approximately 2.5 years)</time_frame>
    <description>PD: a score 4 (uptake moderately &gt;liver) or 5 (uptake markedly &gt;liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event-Free Survival (EFS) According to Investigator as Per Lugano Classification, Using PET or CT Scan</measure>
    <time_frame>Baseline until disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first (assessed up to approximately 2.5 years)</time_frame>
    <description>EFS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) to the date of disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first. PD: a score 4 (uptake moderately &gt;liver) or 5 (uptake markedly &gt;liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan. EFS was calculated using Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Died Due to Any Cause</measure>
    <time_frame>Baseline until death due to any cause (assessed up to approximately 2.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Baseline until death due to any cause (assessed up to approximately 2.5 years)</time_frame>
    <description>OS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) to death due to any cause. For participants who are alive, OS was censored at the last contact. OS was calculated using Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Clearance (CL) of Venetoclax</measure>
    <time_frame>Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)</time_frame>
    <description>CL is a quantitative measure of the rate at which a drug substance is removed from the body.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Volume of Distribution (Vd) of Venetoclax</measure>
    <time_frame>Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)</time_frame>
    <description>Vd was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Maximum Plasma Concentration (Tmax) of Venetoclax</measure>
    <time_frame>Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Plasma Concentration (Cmax) of Venetoclax</measure>
    <time_frame>Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration-Time Curve From Time 0 to Last Observed Concentration (AUClast) of Venetoclax</measure>
    <time_frame>Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)</time_frame>
    <description>Area under the plasma concentration versus time curve from zero to the last measured concentration (AUClast).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration-Time Curve From Time 0 to 8 Hours Post Dose (AUC0-8h) of Venetoclax</measure>
    <time_frame>Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)</time_frame>
    <description>Area under the plasma concentration versus time curve from time 0 (pre-dose) to 8 hours post dose (AUC0-8h).</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">163</enrollment>
  <condition>Follicular Lymphoma</condition>
  <arm_group>
    <arm_group_label>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in will continue until first 9 participants complete the safety observation window of 28 days. Participants will continue receiving the same treatment as decided for Arm B.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle will be of 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive venetoclax at doses decided from safety run-in orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chemotherapy-Containing Cohort: Arm C (BR)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Venetoclax</intervention_name>
    <description>Venetoclax will be administered as per the schedule specified under arm description.</description>
    <arm_group_label>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</arm_group_label>
    <arm_group_label>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</arm_group_label>
    <arm_group_label>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</arm_group_label>
    <other_name>GDC-0199</other_name>
    <other_name>ABT-199</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bendamustine</intervention_name>
    <description>Bendamustine will be administered as per the schedule specified under arm description.</description>
    <arm_group_label>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</arm_group_label>
    <arm_group_label>Chemotherapy-Containing Cohort: Arm C (BR)</arm_group_label>
    <arm_group_label>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</arm_group_label>
    <other_name>Levact</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>Rituximab will be administered as per the schedule specified under arm description.</description>
    <arm_group_label>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</arm_group_label>
    <arm_group_label>Chemotherapy-Containing Cohort: Arm C (BR)</arm_group_label>
    <arm_group_label>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</arm_group_label>
    <arm_group_label>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</arm_group_label>
    <other_name>MabThera</other_name>
    <other_name>Rituxan</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must have histologically confirmed follicular lymphoma (FL) of Grade 1,&#xD;
             2, or 3a&#xD;
&#xD;
          -  Participants must have received at least one prior therapy for FL&#xD;
&#xD;
          -  For participants potentially receiving chemotherapy: if the participant has received&#xD;
             prior bendamustine, response duration must have been greater than (&gt;) 1 year&#xD;
&#xD;
          -  At least one bi-dimensionally measurable lesion on imaging scan defined as &gt;1.5&#xD;
             centimeters (cm) in its longest dimension&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2&#xD;
&#xD;
          -  Adequate hematologic function&#xD;
&#xD;
          -  For female participants of childbearing potential and male participants with female&#xD;
             partners of childbearing potential, agreement to use one highly effective form of&#xD;
             non-hormonal contraception or two effective forms of non-hormonal contraception&#xD;
             throughout the course of study treatment and for at least 30 days after the last dose&#xD;
             of venetoclax and 12 months after the last dose of rituximab, whichever is longer&#xD;
&#xD;
          -  Confirmed availability of archival or freshly biopsied tumor tissue meeting&#xD;
             protocol-defined specifications prior to study enrollment&#xD;
&#xD;
        Exclusion Criteria:&#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;
          -  Contraindication to potential treatment agents&#xD;
&#xD;
          -  Ongoing corticosteroid use &gt;30 milligrams per day (mg/day) of prednisone or&#xD;
             equivalent. Participants receiving corticosteroid treatment with less than equal to&#xD;
             (&lt;/=) 30 mg/day of prednisone or equivalent must be documented to be on a stable dose&#xD;
             of at least 4 weeks duration prior to randomization (Cycle 1 Day 1)&#xD;
&#xD;
          -  Primary central nervous system (CNS) lymphoma&#xD;
&#xD;
          -  Vaccination with live vaccines within 28 days prior to treatment&#xD;
&#xD;
          -  Chemotherapy or other investigational therapy within five half-lives of a biologic&#xD;
             agent with a minimum of 28 days prior to the start of Cycle 1&#xD;
&#xD;
          -  History of other malignancy that could affect compliance with the protocol or&#xD;
             interpretation of results&#xD;
&#xD;
          -  Evidence of significant, uncontrolled concomitant diseases that could affect&#xD;
             compliance with the protocol or interpretation of results or that could increase risk&#xD;
             to the participant&#xD;
&#xD;
          -  Significant cardiovascular disease (such as New York Heart Association Class III or IV&#xD;
             cardiac disease, congestive heart failure, myocardial infarction within the previous 6&#xD;
             months, unstable arrhythmias, or unstable angina) or significant pulmonary disease&#xD;
             (including obstructive pulmonary disease and history of bronchospasm)&#xD;
&#xD;
          -  Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection&#xD;
             (excluding fungal infections of nail beds) at study enrollment or any major episode of&#xD;
             infection requiring treatment with intravenous antibiotics or hospitalization&#xD;
             (relating to the completion of the course of antibiotics) within 4 weeks prior to&#xD;
             Cycle 1 Day 1&#xD;
&#xD;
          -  Requires the use of warfarin&#xD;
&#xD;
          -  Clinically significant history of liver disease, including viral or other hepatitis,&#xD;
             current alcohol abuse, or cirrhosis&#xD;
&#xD;
          -  Presence of positive test results for hepatitis B surface antigen or hepatitis C virus&#xD;
             (HCV) antibody&#xD;
&#xD;
          -  Participants who are positive for HCV antibody must be negative for HCV by polymerase&#xD;
             chain reaction (PCR) to be eligible for study participation&#xD;
&#xD;
          -  Participants with occult or prior hepatitis B virus (HBV) infection may be included if&#xD;
             HBV deoxyribonucleic acid (DNA) is undetectable at screening. These participants must&#xD;
             be willing to undergo monthly HBV DNA test until at least 12 months after the last&#xD;
             treatment cycle&#xD;
&#xD;
          -  Known infection with human immunodeficiency virus (HIV) or human T-cell leukemia virus&#xD;
             1 (HTLV-1)&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Recent major surgery (within 6 weeks before the start of Cycle 1 Day 1), other than&#xD;
             for diagnosis&#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>Southern Cancer Center, PC</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Cancer Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85719</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA School of Medicine; Hematology/Oncology</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nothwest Georgia Oncology Centers P.C</name>
      <address>
        <city>Austell</city>
        <state>Georgia</state>
        <zip>30106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Illinois at Chicago College of Medicine</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612-7302</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Primary Healthcare Associates SC - Harvey</name>
      <address>
        <city>Harvey</city>
        <state>Illinois</state>
        <zip>60426</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas; Medical Center &amp; Medical pavilion</name>
      <address>
        <city>Westwood</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sidney Kimmel Comp Cancer Ctr</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21231-1000</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James P. Wilmot Cancer Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania; School of Medicine</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegheny General Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VCU Massey Cancer Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298-003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia Uni Med. Center - Robert Byrd Health Science</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Prince Alfred Hospital; Medical Oncology</name>
      <address>
        <city>Camperdown</city>
        <state>New South Wales</state>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St George Hospital</name>
      <address>
        <city>Kogarah, New South Wales</city>
        <state>New South Wales</state>
        <zip>2217</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal North Shore Hospital</name>
      <address>
        <city>St. Leonards</city>
        <state>New South Wales</state>
        <zip>2065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westmead Hospital; Haematology</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Calvary Mater Newcastle</name>
      <address>
        <city>Waratah</city>
        <state>New South Wales</state>
        <zip>2298</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Townsville General Hospital</name>
      <address>
        <city>Douglas</city>
        <state>Queensland</state>
        <zip>4184</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Alexandra Hospital</name>
      <address>
        <city>Woolloongabba</city>
        <state>Queensland</state>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital; Haematology</name>
      <address>
        <city>Woodville South</city>
        <state>South Australia</state>
        <zip>5011</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Hobart Hospital</name>
      <address>
        <city>Hobart</city>
        <state>Tasmania</state>
        <zip>7000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Medical Centre</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ZNA Stuivenberg</name>
      <address>
        <city>Antwerpen</city>
        <zip>2060</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Sint Jan</name>
      <address>
        <city>Brugge</city>
        <zip>8000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires St-Luc</name>
      <address>
        <city>Bruxelles</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>British Columbia Cancer Agency</name>
      <address>
        <city>Kelowna</city>
        <state>British Columbia</state>
        <zip>V1Y 5L3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health Network; Princess Margaret Hospital; Medical Oncology Dept</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Maisonneuve- Rosemont; Oncology</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T 2M4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chum Hopital Notre Dame; Centre D'Oncologie</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2L 4M1</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>Saskatoon Cancer Centre; Uni of Saskatoon Campus</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7N 4H4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de Cancerologie de l'Ouest</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Clermont Ferrand - Hôpital d'Estaing</name>
      <address>
        <city>Clermont Ferrand cedex 1</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Henri Mondor</name>
      <address>
        <city>Creteil</city>
        <zip>94010</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>Centre Jean Bernard</name>
      <address>
        <city>Le Mans</city>
        <zip>72015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Lyon Sud; Hematolgie</name>
      <address>
        <city>Pierre Benite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Chemnitz gGmbH; Klinik f. Innere Medizin III</name>
      <address>
        <city>Chemnitz</city>
        <zip>09116</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Städtisches Klinikum Dessau</name>
      <address>
        <city>Dessau-Roßlau</city>
        <zip>06847</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>Universitätsklinik Essen; Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie</name>
      <address>
        <city>Essen</city>
        <zip>45122</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Jena; Klinik für Innere Medizin II</name>
      <address>
        <city>Jena</city>
        <zip>07747</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Köln; Klinik I für Innere Medizin</name>
      <address>
        <city>Koeln</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Schleswig-Holstein / Campus Lübeck, Med. Klinik I, Hämatologie/Onkologie</name>
      <address>
        <city>Lübeck</city>
        <zip>23562</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Ulm; Apotheke</name>
      <address>
        <city>Ulm</city>
        <zip>89075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie</name>
      <address>
        <city>Würzburg</city>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna</name>
      <address>
        <city>Bologna</city>
        <state>Emilia-Romagna</state>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica</name>
      <address>
        <city>Meldola</city>
        <state>Emilia-Romagna</state>
        <zip>47014</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale di Ravenna</name>
      <address>
        <city>Ravenna</city>
        <state>Emilia-Romagna</state>
        <zip>48100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Infermi di Rimini</name>
      <address>
        <city>Rimini</city>
        <state>Emilia-Romagna</state>
        <zip>47900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asst Papa Giovanni XXIII</name>
      <address>
        <city>Bergamo</city>
        <state>Lombardia</state>
        <zip>24100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Niguarda Milano</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Irccs Policlinico San Matteo; Divisione Di Ematologia</name>
      <address>
        <city>Pavia</city>
        <state>Lombardia</state>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedale San Giovanni</name>
      <address>
        <city>Torino</city>
        <state>Piemonte</state>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Az. Osp. Di Careggi; Divisione Di Ematologia</name>
      <address>
        <city>Firenze</city>
        <state>Toscana</state>
        <zip>50135</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Blackpool Victoria Hospital</name>
      <address>
        <city>Blackpool</city>
        <zip>FY3 8NR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St James University Hospital</name>
      <address>
        <city>Leeds</city>
        <zip>LS9 7TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leicester Royal Infirmary; Dept. of Medical Oncology</name>
      <address>
        <city>Leicester</city>
        <zip>LE1 5WW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College London, Department of Haematology</name>
      <address>
        <city>London</city>
        <zip>NW1 2PG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Marsden Nhs Trust; Consultant Cancer Physician</name>
      <address>
        <city>London</city>
        <zip>SW3 6JJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christie Hospital; Breast Cancer Research Office</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4QL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Churchill Hospital; Oxford Cancer and Haematology Centre</name>
      <address>
        <city>Oxford</city>
        <zip>OX3 7LJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Marsden NHS Foundation Trust</name>
      <address>
        <city>Sutton</city>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <results_first_submitted>September 15, 2017</results_first_submitted>
  <results_first_submitted_qc>September 15, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">October 13, 2017</results_first_posted>
  <last_update_submitted>June 3, 2019</last_update_submitted>
  <last_update_submitted_qc>June 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2019</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>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Follicular</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rituximab</mesh_term>
    <mesh_term>Venetoclax</mesh_term>
    <mesh_term>Bendamustine Hydrochloride</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</title>
          <description>Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
        </group>
        <group group_id="P2">
          <title>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</title>
          <description>Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.</description>
        </group>
        <group group_id="P3">
          <title>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</title>
          <description>Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
        </group>
        <group group_id="P4">
          <title>Chemotherapy-Containing Cohort: Arm C (BR)</title>
          <description>Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="52"/>
                <participants group_id="P3" count="51"/>
                <participants group_id="P4" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="52"/>
                <participants group_id="P3" count="49"/>
                <participants group_id="P4" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="19"/>
                <participants group_id="P4" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="48"/>
                <participants group_id="P3" count="32"/>
                <participants group_id="P4" count="32"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive Disease</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="42"/>
                <participants group_id="P3" count="19"/>
                <participants group_id="P4" count="22"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent-to-treat (ITT) population included all enrolled participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</title>
          <description>Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
        </group>
        <group group_id="B2">
          <title>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</title>
          <description>Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.</description>
        </group>
        <group group_id="B3">
          <title>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</title>
          <description>Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
        </group>
        <group group_id="B4">
          <title>Chemotherapy-Containing Cohort: Arm C (BR)</title>
          <description>Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
        </group>
        <group group_id="B5">
          <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="9"/>
            <count group_id="B2" value="52"/>
            <count group_id="B3" value="51"/>
            <count group_id="B4" value="51"/>
            <count group_id="B5" value="163"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.9" spread="12.7"/>
                    <measurement group_id="B2" value="61.9" spread="12.0"/>
                    <measurement group_id="B3" value="64.9" spread="9.8"/>
                    <measurement group_id="B4" value="61.0" spread="11.6"/>
                    <measurement group_id="B5" value="62.3" spread="11.3"/>
                  </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="5"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="21"/>
                    <measurement group_id="B5" value="67"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="35"/>
                    <measurement group_id="B4" value="30"/>
                    <measurement group_id="B5" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Complete Metabolic Response (CMR) According to Independent Review Committee (IRC) as Per Lugano Classification, Using Positron Emission Tomography (PET) Scan at Primary Response Assessment (PRA)</title>
        <description>CMR: a score 1 (no uptake above background), 2 (uptake less than or equal to [&lt;=] mediastinum), or 3 (uptake less than [&lt;] mediastinum but &lt;=liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites with no new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method.</description>
        <time_frame>6-8 weeks after Cycle 6 Day 1 (PRA) (Cycle length = 28 days)</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</title>
            <description>Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</title>
            <description>Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</title>
            <description>Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O4">
            <title>Chemotherapy-Containing Cohort: Arm C (BR)</title>
            <description>Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Complete Metabolic Response (CMR) According to Independent Review Committee (IRC) as Per Lugano Classification, Using Positron Emission Tomography (PET) Scan at Primary Response Assessment (PRA)</title>
          <description>CMR: a score 1 (no uptake above background), 2 (uptake less than or equal to [&lt;=] mediastinum), or 3 (uptake less than [&lt;] mediastinum but &lt;=liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites with no new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method.</description>
          <population>ITT population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.6" lower_limit="21.20" upper_limit="86.30"/>
                    <measurement group_id="O2" value="11.5" lower_limit="4.35" upper_limit="23.44"/>
                    <measurement group_id="O3" value="74.5" lower_limit="60.37" upper_limit="85.67"/>
                    <measurement group_id="O4" value="70.6" lower_limit="56.17" upper_limit="82.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in response rates</param_type>
            <param_value>3.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.38</ci_lower_limit>
            <ci_upper_limit>21.23</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With CMR According to Investigator as Per Lugano Classification, Using PET Scan at PRA</title>
        <description>CMR: a score 1 (no uptake above background), 2 (uptake &lt;=mediastinum), or 3 (&lt;mediastinum but &lt;=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.</description>
        <time_frame>4-10 weeks after Cycle 6 Day 1 (Cycle length = 28 days)</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</title>
            <description>Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</title>
            <description>Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</title>
            <description>Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O4">
            <title>Chemotherapy-Containing Cohort: Arm C (BR)</title>
            <description>Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With CMR According to Investigator as Per Lugano Classification, Using PET Scan at PRA</title>
          <description>CMR: a score 1 (no uptake above background), 2 (uptake &lt;=mediastinum), or 3 (&lt;mediastinum but &lt;=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.</description>
          <population>ITT population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.6" lower_limit="21.20" upper_limit="86.30"/>
                    <measurement group_id="O2" value="15.4" lower_limit="6.88" upper_limit="28.08"/>
                    <measurement group_id="O3" value="70.6" lower_limit="56.17" upper_limit="82.51"/>
                    <measurement group_id="O4" value="68.6" lower_limit="54.11" upper_limit="80.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in response rates</param_type>
            <param_value>1.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.89</ci_lower_limit>
            <ci_upper_limit>19.81</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With CMR According to IRC as Per Lugano Classification, Using PET Scan at Year 1</title>
        <description>CMR: a score 1 (no uptake above background), 2 (uptake &lt;=mediastinum), or 3 (uptake &lt;mediastinum but &lt;=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.</description>
        <time_frame>48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</title>
            <description>Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</title>
            <description>Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</title>
            <description>Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O4">
            <title>Chemotherapy-Containing Cohort: Arm C (BR)</title>
            <description>Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With CMR According to IRC as Per Lugano Classification, Using PET Scan at Year 1</title>
          <description>CMR: a score 1 (no uptake above background), 2 (uptake &lt;=mediastinum), or 3 (uptake &lt;mediastinum but &lt;=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.</description>
          <population>ITT population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.6" lower_limit="21.20" upper_limit="86.30"/>
                    <measurement group_id="O2" value="21.2" lower_limit="11.06" upper_limit="34.70"/>
                    <measurement group_id="O3" value="41.2" lower_limit="27.58" upper_limit="55.83"/>
                    <measurement group_id="O4" value="39.2" lower_limit="25.84" upper_limit="53.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in response rates</param_type>
            <param_value>1.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-17.07</ci_lower_limit>
            <ci_upper_limit>20.99</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With CMR According to Investigator as Per Lugano Classification, Using PET Scan at Year 1</title>
        <description>CMR: a score 1 (no uptake above background), 2 (uptake &lt;=mediastinum), or 3 (&lt;mediastinum but &lt;=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.</description>
        <time_frame>48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</title>
            <description>Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</title>
            <description>Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</title>
            <description>Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O4">
            <title>Chemotherapy-Containing Cohort: Arm C (BR)</title>
            <description>Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With CMR According to Investigator as Per Lugano Classification, Using PET Scan at Year 1</title>
          <description>CMR: a score 1 (no uptake above background), 2 (uptake &lt;=mediastinum), or 3 (&lt;mediastinum but &lt;=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.</description>
          <population>ITT population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.6" lower_limit="21.20" upper_limit="86.30"/>
                    <measurement group_id="O2" value="17.3" lower_limit="8.23" upper_limit="30.33"/>
                    <measurement group_id="O3" value="39.2" lower_limit="25.84" upper_limit="53.89"/>
                    <measurement group_id="O4" value="47.1" lower_limit="32.93" upper_limit="61.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in response rates</param_type>
            <param_value>-7.84</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-27.01</ci_lower_limit>
            <ci_upper_limit>11.32</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Complete Response (CR) According to IRC as Per Lugano Classification, Using Computed Tomography (CT) Scan</title>
        <description>CR: defined as reduction of longest transverse diameter of lesion (LDi) of target nodes/nodal masses to &lt;=1.5 centimeters (cm), and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/immunohistochemistry (IHC)-negative bone marrow morphology. Assessment was performed by an IRC according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.</description>
        <time_frame>6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</title>
            <description>Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</title>
            <description>Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</title>
            <description>Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O4">
            <title>Chemotherapy-Containing Cohort: Arm C (BR)</title>
            <description>Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Complete Response (CR) According to IRC as Per Lugano Classification, Using Computed Tomography (CT) Scan</title>
          <description>CR: defined as reduction of longest transverse diameter of lesion (LDi) of target nodes/nodal masses to &lt;=1.5 centimeters (cm), and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/immunohistochemistry (IHC)-negative bone marrow morphology. Assessment was performed by an IRC according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.</description>
          <population>ITT population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6-8 weeks after Cycle 6 Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.4" lower_limit="13.70" upper_limit="78.80"/>
                    <measurement group_id="O2" value="5.7" lower_limit="1.18" upper_limit="15.66"/>
                    <measurement group_id="O3" value="39.2" lower_limit="25.84" upper_limit="53.89"/>
                    <measurement group_id="O4" value="25.5" lower_limit="14.33" upper_limit="39.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.6" lower_limit="21.20" upper_limit="86.30"/>
                    <measurement group_id="O2" value="13.2" lower_limit="5.48" upper_limit="25.34"/>
                    <measurement group_id="O3" value="27.5" lower_limit="15.89" upper_limit="41.74"/>
                    <measurement group_id="O4" value="23.5" lower_limit="12.79" upper_limit="37.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>At 6-8 weeks after Cycle 6 Day 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in response rates</param_type>
            <param_value>13.73</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.24</ci_lower_limit>
            <ci_upper_limit>31.69</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>At Year 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in response rates</param_type>
            <param_value>3.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.98</ci_lower_limit>
            <ci_upper_limit>20.82</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With CR According to Investigator as Per Lugano Classification, Using CT Scan</title>
        <description>CR: defined as reduction of LDi of target nodes/nodal masses to &lt;=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. Assessment was performed by Investigator according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.</description>
        <time_frame>4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</title>
            <description>Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</title>
            <description>Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</title>
            <description>Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O4">
            <title>Chemotherapy-Containing Cohort: Arm C (BR)</title>
            <description>Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With CR According to Investigator as Per Lugano Classification, Using CT Scan</title>
          <description>CR: defined as reduction of LDi of target nodes/nodal masses to &lt;=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. Assessment was performed by Investigator according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.</description>
          <population>ITT population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>4-10 weeks after Cycle 6 Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.2" lower_limit="2.81" upper_limit="60.01"/>
                    <measurement group_id="O2" value="5.7" lower_limit="1.18" upper_limit="15.66"/>
                    <measurement group_id="O3" value="15.7" lower_limit="7.02" upper_limit="28.59"/>
                    <measurement group_id="O4" value="31.4" lower_limit="19.11" upper_limit="45.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3" lower_limit="7.49" upper_limit="70.07"/>
                    <measurement group_id="O2" value="5.7" lower_limit="1.18" upper_limit="15.66"/>
                    <measurement group_id="O3" value="13.7" lower_limit="5.70" upper_limit="26.26"/>
                    <measurement group_id="O4" value="21.6" lower_limit="11.29" upper_limit="35.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>At 4-10 weeks after Cycle 6 Day 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in response rates</param_type>
            <param_value>-15.69</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-31.87</ci_lower_limit>
            <ci_upper_limit>0.49</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>At Year 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in response rates</param_type>
            <param_value>-7.84</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-22.56</ci_lower_limit>
            <ci_upper_limit>6.87</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Objective Response (OR) According to IRC as Per Lugano Classification, Using PET Scan</title>
        <description>OR was defined as CMR or Partial Metabolic Response (PMR). CMR: a score 1 (no uptake above background), 2 (uptake &lt;=mediastinum), or 3 (&lt;mediastinum but &lt;=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. PMR: a score 4 (uptake moderately greater than [&gt;] liver) or 5 (uptake markedly &gt;liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.</description>
        <time_frame>6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</title>
            <description>Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</title>
            <description>Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</title>
            <description>Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O4">
            <title>Chemotherapy-Containing Cohort: Arm C (BR)</title>
            <description>Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Objective Response (OR) According to IRC as Per Lugano Classification, Using PET Scan</title>
          <description>OR was defined as CMR or Partial Metabolic Response (PMR). CMR: a score 1 (no uptake above background), 2 (uptake &lt;=mediastinum), or 3 (&lt;mediastinum but &lt;=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. PMR: a score 4 (uptake moderately greater than [&gt;] liver) or 5 (uptake markedly &gt;liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.</description>
          <population>ITT population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6-8 weeks after Cycle 6 Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.6" lower_limit="21.20" upper_limit="86.30"/>
                    <measurement group_id="O2" value="21.2" lower_limit="11.06" upper_limit="34.70"/>
                    <measurement group_id="O3" value="76.5" lower_limit="62.51" upper_limit="87.21"/>
                    <measurement group_id="O4" value="74.5" lower_limit="60.37" upper_limit="85.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.7" lower_limit="29.93" upper_limit="92.51"/>
                    <measurement group_id="O2" value="32.7" lower_limit="20.33" upper_limit="47.11"/>
                    <measurement group_id="O3" value="45.1" lower_limit="31.13" upper_limit="59.66"/>
                    <measurement group_id="O4" value="51.0" lower_limit="36.60" upper_limit="65.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using PET Scan</title>
        <description>OR was defined as CMR or PMR. CMR: a score 1 (no uptake above background), 2 (uptake &lt;=mediastinum), or 3 (&lt;mediastinum but &lt;=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. PMR: a score 4 (uptake moderately &gt;liver) or 5 (uptake markedly &gt;liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.</description>
        <time_frame>4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</title>
            <description>Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</title>
            <description>Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</title>
            <description>Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O4">
            <title>Chemotherapy-Containing Cohort: Arm C (BR)</title>
            <description>Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using PET Scan</title>
          <description>OR was defined as CMR or PMR. CMR: a score 1 (no uptake above background), 2 (uptake &lt;=mediastinum), or 3 (&lt;mediastinum but &lt;=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. PMR: a score 4 (uptake moderately &gt;liver) or 5 (uptake markedly &gt;liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.</description>
          <population>ITT population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>4-10 weeks after Cycle 6 Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.6" lower_limit="21.20" upper_limit="86.30"/>
                    <measurement group_id="O2" value="28.8" lower_limit="17.13" upper_limit="43.08"/>
                    <measurement group_id="O3" value="76.5" lower_limit="62.51" upper_limit="87.21"/>
                    <measurement group_id="O4" value="76.5" lower_limit="62.51" upper_limit="87.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.6" lower_limit="21.20" upper_limit="86.30"/>
                    <measurement group_id="O2" value="21.2" lower_limit="11.06" upper_limit="34.70"/>
                    <measurement group_id="O3" value="39.2" lower_limit="25.84" upper_limit="53.89"/>
                    <measurement group_id="O4" value="49.0" lower_limit="34.75" upper_limit="63.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With OR According to IRC as Per Lugano Classification, Using CT Scan</title>
        <description>OR was defined as CR or Partial Response (PR). CR: reduction of LDi of target nodes/nodal masses to &lt;=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. PR: greater than or equal to (&gt;=) 50 percent (%) decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen at least &gt;50% beyond normal; and no new lesions. Assessment was performed by an IRC according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.</description>
        <time_frame>6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</title>
            <description>Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</title>
            <description>Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</title>
            <description>Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O4">
            <title>Chemotherapy-Containing Cohort: Arm C (BR)</title>
            <description>Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With OR According to IRC as Per Lugano Classification, Using CT Scan</title>
          <description>OR was defined as CR or Partial Response (PR). CR: reduction of LDi of target nodes/nodal masses to &lt;=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. PR: greater than or equal to (&gt;=) 50 percent (%) decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen at least &gt;50% beyond normal; and no new lesions. Assessment was performed by an IRC according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.</description>
          <population>ITT population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6-8 weeks after Cycle 6 Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.7" lower_limit="29.93" upper_limit="92.51"/>
                    <measurement group_id="O2" value="30.2" lower_limit="18.34" upper_limit="44.34"/>
                    <measurement group_id="O3" value="80.4" lower_limit="66.88" upper_limit="90.18"/>
                    <measurement group_id="O4" value="84.3" lower_limit="71.41" upper_limit="92.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.7" lower_limit="29.93" upper_limit="92.51"/>
                    <measurement group_id="O2" value="22.6" lower_limit="12.28" upper_limit="36.21"/>
                    <measurement group_id="O3" value="41.2" lower_limit="27.58" upper_limit="55.83"/>
                    <measurement group_id="O4" value="60.8" lower_limit="46.11" upper_limit="74.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using CT Scan</title>
        <description>OR was defined as CR or PR. CR: reduction of LDi of target nodes/nodal masses to &lt;=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. PR: &gt;=50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen at least &gt;50% beyond normal; and no new lesions. Assessment was performed by Investigator according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.</description>
        <time_frame>4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</title>
            <description>Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</title>
            <description>Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</title>
            <description>Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O4">
            <title>Chemotherapy-Containing Cohort: Arm C (BR)</title>
            <description>Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using CT Scan</title>
          <description>OR was defined as CR or PR. CR: reduction of LDi of target nodes/nodal masses to &lt;=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. PR: &gt;=50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen at least &gt;50% beyond normal; and no new lesions. Assessment was performed by Investigator according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.</description>
          <population>ITT population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>4-10 weeks after Cycle 6 Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.6" lower_limit="21.20" upper_limit="86.30"/>
                    <measurement group_id="O2" value="32.1" lower_limit="19.92" upper_limit="46.32"/>
                    <measurement group_id="O3" value="74.5" lower_limit="60.37" upper_limit="85.67"/>
                    <measurement group_id="O4" value="78.4" lower_limit="64.68" upper_limit="88.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.6" lower_limit="21.20" upper_limit="86.30"/>
                    <measurement group_id="O2" value="28.3" lower_limit="16.79" upper_limit="42.35"/>
                    <measurement group_id="O3" value="47.1" lower_limit="32.93" upper_limit="61.54"/>
                    <measurement group_id="O4" value="49.0" lower_limit="34.75" upper_limit="63.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using PET or CT Scan</title>
        <description>OR was defined as CMR/CR or PMR/PR. CMR, CR, PMR, and PR have been defined in previous endpoints, and are not repeated here due to space constraint. Assessment was performed by Investigator according to Lugano classification using PET scan or CT scan (if PET is missing).</description>
        <time_frame>Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years)</time_frame>
        <population>ITT population. 'Overall number of participants analyzed'=those evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</title>
            <description>Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</title>
            <description>Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</title>
            <description>Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O4">
            <title>Chemotherapy-Containing Cohort: Arm C (BR)</title>
            <description>Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using PET or CT Scan</title>
          <description>OR was defined as CMR/CR or PMR/PR. CMR, CR, PMR, and PR have been defined in previous endpoints, and are not repeated here due to space constraint. Assessment was performed by Investigator according to Lugano classification using PET scan or CT scan (if PET is missing).</description>
          <population>ITT population. 'Overall number of participants analyzed'=those evaluable for this outcome measure.</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="9"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.7" lower_limit="29.93" upper_limit="92.51"/>
                    <measurement group_id="O2" value="36.5" lower_limit="23.62" upper_limit="51.04"/>
                    <measurement group_id="O3" value="80.4" lower_limit="66.88" upper_limit="90.18"/>
                    <measurement group_id="O4" value="80.4" lower_limit="66.88" upper_limit="90.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DOR) According to Investigator as Per Lugano Classification, Using PET or CT Scan</title>
        <description>DOR was defined as time from CMR/CR or PMR/PR until progressive disease (PD) or death due to any cause. CMR, CR, PMR, and PR have been defined in previous endpoints, and are not repeated here due to space constraint. PD: a score 4 (uptake moderately &gt;liver) or 5 (uptake markedly &gt;liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan or CT scan (if PET is missing). DOR was calculated using Kaplan-Meier method.</description>
        <time_frame>From CMR or PMR until disease progression or death due to any cause (assessed up to approximately 2.5 years)</time_frame>
        <population>ITT population. 'Overall number of participants analyzed'=those evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</title>
            <description>Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</title>
            <description>Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</title>
            <description>Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O4">
            <title>Chemotherapy-Containing Cohort: Arm C (BR)</title>
            <description>Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response (DOR) According to Investigator as Per Lugano Classification, Using PET or CT Scan</title>
          <description>DOR was defined as time from CMR/CR or PMR/PR until progressive disease (PD) or death due to any cause. CMR, CR, PMR, and PR have been defined in previous endpoints, and are not repeated here due to space constraint. PD: a score 4 (uptake moderately &gt;liver) or 5 (uptake markedly &gt;liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan or CT scan (if PET is missing). DOR was calculated using Kaplan-Meier method.</description>
          <population>ITT population. 'Overall number of participants analyzed'=those evaluable for this outcome measure.</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="9"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="47"/>
                <count group_id="O4" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.46" lower_limit="9.46" upper_limit="32.46"/>
                    <measurement group_id="O2" value="15.79" lower_limit="10.15" upper_limit="23.49"/>
                    <measurement group_id="O3" value="24.87" lower_limit="12.45" upper_limit="NA">Upper limit of 95% CI could not be calculated due to the low number of participants with event.</measurement>
                    <measurement group_id="O4" value="15.64" lower_limit="12.09" upper_limit="NA">Upper limit of 95% CI could not be calculated due to the low number of participants with event.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Stratified Analysis: Strata were disease burden and DOR of prior cancer therapy.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.69</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.38</ci_lower_limit>
            <ci_upper_limit>1.27</ci_upper_limit>
            <estimate_desc>HR was calculated using Cox regression.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Unstratified Analysis</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.78</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.43</ci_lower_limit>
            <ci_upper_limit>1.40</ci_upper_limit>
            <estimate_desc>HR was calculated using Cox regression.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Disease Progression (According to Investigator as Per Lugano Classification, Using PET or CT Scan) or Death</title>
        <description>PD: a score 4 (uptake moderately &gt;liver) or 5 (uptake markedly &gt;liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan.</description>
        <time_frame>Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years)</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</title>
            <description>Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</title>
            <description>Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</title>
            <description>Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O4">
            <title>Chemotherapy-Containing Cohort: Arm C (BR)</title>
            <description>Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Disease Progression (According to Investigator as Per Lugano Classification, Using PET or CT Scan) or Death</title>
          <description>PD: a score 4 (uptake moderately &gt;liver) or 5 (uptake markedly &gt;liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan.</description>
          <population>ITT population</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="9"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.4"/>
                    <measurement group_id="O2" value="86.5"/>
                    <measurement group_id="O3" value="41.2"/>
                    <measurement group_id="O4" value="52.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-Free Survival (PFS) According to Investigator as Per Lugano Classification, Using PET or CT Scan</title>
        <description>PFS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) until the date of disease progression, or death due to any cause. PD: a score 4 (uptake moderately &gt;liver) or 5 (uptake markedly &gt;liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan. PFS was calculated using Kaplan-Meier method.</description>
        <time_frame>Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years)</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</title>
            <description>Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</title>
            <description>Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</title>
            <description>Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O4">
            <title>Chemotherapy-Containing Cohort: Arm C (BR)</title>
            <description>Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-Free Survival (PFS) According to Investigator as Per Lugano Classification, Using PET or CT Scan</title>
          <description>PFS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) until the date of disease progression, or death due to any cause. PD: a score 4 (uptake moderately &gt;liver) or 5 (uptake markedly &gt;liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan. PFS was calculated using Kaplan-Meier method.</description>
          <population>ITT population</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="9"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.09" lower_limit="12.78" upper_limit="35.09"/>
                    <measurement group_id="O2" value="6.57" lower_limit="6.18" upper_limit="12.25"/>
                    <measurement group_id="O3" value="27.63" lower_limit="16.07" upper_limit="NA">Upper limit of 95% CI could not be calculated due to the low number of participants with event.</measurement>
                    <measurement group_id="O4" value="18.43" lower_limit="16.92" upper_limit="NA">Upper limit of 95% CI could not be calculated due to the low number of participants with event.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Stratified Analysis: Strata were disease burden and PFS of prior cancer therapy.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.69</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.38</ci_lower_limit>
            <ci_upper_limit>1.24</ci_upper_limit>
            <estimate_desc>HR was calculated using Cox regression.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Unstratified Analysis</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.43</ci_lower_limit>
            <ci_upper_limit>1.36</ci_upper_limit>
            <estimate_desc>HR was calculated using Cox regression.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Disease Progression (According to Investigator as Per Lugano Classification, Using PET or CT Scan), Death, or Start of a New Anti-lymphoma Therapy</title>
        <description>PD: a score 4 (uptake moderately &gt;liver) or 5 (uptake markedly &gt;liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan.</description>
        <time_frame>Baseline until disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first (assessed up to approximately 2.5 years)</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</title>
            <description>Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</title>
            <description>Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</title>
            <description>Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O4">
            <title>Chemotherapy-Containing Cohort: Arm C (BR)</title>
            <description>Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Disease Progression (According to Investigator as Per Lugano Classification, Using PET or CT Scan), Death, or Start of a New Anti-lymphoma Therapy</title>
          <description>PD: a score 4 (uptake moderately &gt;liver) or 5 (uptake markedly &gt;liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan.</description>
          <population>ITT population</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="9"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.4"/>
                    <measurement group_id="O2" value="86.5"/>
                    <measurement group_id="O3" value="41.2"/>
                    <measurement group_id="O4" value="52.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Event-Free Survival (EFS) According to Investigator as Per Lugano Classification, Using PET or CT Scan</title>
        <description>EFS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) to the date of disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first. PD: a score 4 (uptake moderately &gt;liver) or 5 (uptake markedly &gt;liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan. EFS was calculated using Kaplan-Meier method.</description>
        <time_frame>Baseline until disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first (assessed up to approximately 2.5 years)</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</title>
            <description>Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</title>
            <description>Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</title>
            <description>Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O4">
            <title>Chemotherapy-Containing Cohort: Arm C (BR)</title>
            <description>Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Event-Free Survival (EFS) According to Investigator as Per Lugano Classification, Using PET or CT Scan</title>
          <description>EFS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) to the date of disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first. PD: a score 4 (uptake moderately &gt;liver) or 5 (uptake markedly &gt;liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan. EFS was calculated using Kaplan-Meier method.</description>
          <population>ITT population</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="9"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.09" lower_limit="12.78" upper_limit="35.09"/>
                    <measurement group_id="O2" value="6.57" lower_limit="6.18" upper_limit="12.25"/>
                    <measurement group_id="O3" value="27.63" lower_limit="16.07" upper_limit="NA">Upper limit of 95% CI could not be calculated due to the low number of participants with event.</measurement>
                    <measurement group_id="O4" value="18.43" lower_limit="16.92" upper_limit="NA">Upper limit of 95% CI could not be calculated due to the low number of participants with event.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Stratified Analysis: Strata were disease burden and EFS of prior cancer therapy.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.69</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.38</ci_lower_limit>
            <ci_upper_limit>1.24</ci_upper_limit>
            <estimate_desc>HR was calculated using Cox regression.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Unstratified Analysis</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.43</ci_lower_limit>
            <ci_upper_limit>1.36</ci_upper_limit>
            <estimate_desc>HR was calculated using Cox regression.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Died Due to Any Cause</title>
        <time_frame>Baseline until death due to any cause (assessed up to approximately 2.5 years</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</title>
            <description>Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</title>
            <description>Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</title>
            <description>Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O4">
            <title>Chemotherapy-Containing Cohort: Arm C (BR)</title>
            <description>Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Died Due to Any Cause</title>
          <population>ITT population</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="9"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="5.8"/>
                    <measurement group_id="O3" value="2.0"/>
                    <measurement group_id="O4" value="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>OS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) to death due to any cause. For participants who are alive, OS was censored at the last contact. OS was calculated using Kaplan-Meier method.</description>
        <time_frame>Baseline until death due to any cause (assessed up to approximately 2.5 years)</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</title>
            <description>Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</title>
            <description>Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</title>
            <description>Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O4">
            <title>Chemotherapy-Containing Cohort: Arm C (BR)</title>
            <description>Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>OS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) to death due to any cause. For participants who are alive, OS was censored at the last contact. OS was calculated using Kaplan-Meier method.</description>
          <population>ITT population</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="9"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Median and corresponding 95% CI could not be estimated due to higher number of censored participants.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Median and corresponding 95% CI could not be estimated due to higher number of censored participants.</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">Median and corresponding 95% CI could not be estimated due to higher number of censored participants.</measurement>
                    <measurement group_id="O4" value="NA" lower_limit="NA" upper_limit="NA">Median and corresponding 95% CI could not be estimated due to higher number of censored participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Stratified Analysis: Strata were disease burden and OS of prior cancer therapy.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.48</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.04</ci_lower_limit>
            <ci_upper_limit>5.37</ci_upper_limit>
            <estimate_desc>HR was calculated using Cox regression.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Unstratified Analysis</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.51</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.05</ci_lower_limit>
            <ci_upper_limit>5.63</ci_upper_limit>
            <estimate_desc>HR was calculated using Cox regression.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Clearance (CL) of Venetoclax</title>
        <description>CL is a quantitative measure of the rate at which a drug substance is removed from the body.</description>
        <time_frame>Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)</time_frame>
        <population>The data could not be collected as the timepoints for pharmacokinetics collection and the daily dosing of venetoclax did not permit an assessment of CL.</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</title>
            <description>Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</title>
            <description>Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</title>
            <description>Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Clearance (CL) of Venetoclax</title>
          <description>CL is a quantitative measure of the rate at which a drug substance is removed from the body.</description>
          <population>The data could not be collected as the timepoints for pharmacokinetics collection and the daily dosing of venetoclax did not permit an assessment of CL.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Volume of Distribution (Vd) of Venetoclax</title>
        <description>Vd was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.</description>
        <time_frame>Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)</time_frame>
        <population>The data could not be collected as the timepoints for pharmacokinetics collection and the daily dosing of venetoclax did not permit an assessment of Vd.</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</title>
            <description>Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</title>
            <description>Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</title>
            <description>Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Volume of Distribution (Vd) of Venetoclax</title>
          <description>Vd was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.</description>
          <population>The data could not be collected as the timepoints for pharmacokinetics collection and the daily dosing of venetoclax did not permit an assessment of Vd.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Maximum Plasma Concentration (Tmax) of Venetoclax</title>
        <time_frame>Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)</time_frame>
        <population>Pharmacokinetic-evaluable population included all enrolled participants with available pharmacokinetic data for venetoclax.</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</title>
            <description>Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</title>
            <description>Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</title>
            <description>Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Maximum Plasma Concentration (Tmax) of Venetoclax</title>
          <population>Pharmacokinetic-evaluable population included all enrolled participants with available pharmacokinetic data for venetoclax.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="51"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.00" lower_limit="4.00" upper_limit="8.08"/>
                    <measurement group_id="O2" value="6.00" lower_limit="1.95" upper_limit="8.18"/>
                    <measurement group_id="O3" value="6.21" lower_limit="1.98" upper_limit="9.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Plasma Concentration (Cmax) of Venetoclax</title>
        <time_frame>Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)</time_frame>
        <population>Pharmacokinetic-evaluable population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</title>
            <description>Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</title>
            <description>Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</title>
            <description>Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Plasma Concentration (Cmax) of Venetoclax</title>
          <population>Pharmacokinetic-evaluable population</population>
          <units>nanograms per milliliter (ng/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="51"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1350" spread="427"/>
                    <measurement group_id="O2" value="1220" spread="478"/>
                    <measurement group_id="O3" value="1340" spread="460"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Plasma Concentration-Time Curve From Time 0 to Last Observed Concentration (AUClast) of Venetoclax</title>
        <description>Area under the plasma concentration versus time curve from zero to the last measured concentration (AUClast).</description>
        <time_frame>Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)</time_frame>
        <population>Pharmacokinetic-evaluable population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</title>
            <description>Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</title>
            <description>Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</title>
            <description>Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration-Time Curve From Time 0 to Last Observed Concentration (AUClast) of Venetoclax</title>
          <description>Area under the plasma concentration versus time curve from zero to the last measured concentration (AUClast).</description>
          <population>Pharmacokinetic-evaluable population</population>
          <units>hours*ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="51"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5310" spread="1730"/>
                    <measurement group_id="O2" value="4950" spread="1950"/>
                    <measurement group_id="O3" value="5500" spread="2270"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Plasma Concentration-Time Curve From Time 0 to 8 Hours Post Dose (AUC0-8h) of Venetoclax</title>
        <description>Area under the plasma concentration versus time curve from time 0 (pre-dose) to 8 hours post dose (AUC0-8h).</description>
        <time_frame>Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)</time_frame>
        <population>Pharmacokinetic-evaluable population. 'Overall number of participants analyzed'=those evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</title>
            <description>Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</title>
            <description>Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.</description>
          </group>
          <group group_id="O3">
            <title>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</title>
            <description>Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration-Time Curve From Time 0 to 8 Hours Post Dose (AUC0-8h) of Venetoclax</title>
          <description>Area under the plasma concentration versus time curve from time 0 (pre-dose) to 8 hours post dose (AUC0-8h).</description>
          <population>Pharmacokinetic-evaluable population. 'Overall number of participants analyzed'=those evaluable for this outcome measure.</population>
          <units>hours*ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5240" spread="1860"/>
                    <measurement group_id="O2" value="4820" spread="1980"/>
                    <measurement group_id="O3" value="5330" spread="2270"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to approximately 2.5 years</time_frame>
      <desc>Safety-evaluable population included participants who received at least one dose of any study treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)</title>
          <description>Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
        </group>
        <group group_id="E2">
          <title>Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)</title>
          <description>Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.</description>
        </group>
        <group group_id="E3">
          <title>Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)</title>
          <description>Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
        </group>
        <group group_id="E4">
          <title>Chemotherapy-Containing Cohort: Arm C (BR)</title>
          <description>Participants received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 21.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Aplastic anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>NEUTROPENIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute left ventricular failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>ACUTE CORONARY SYNDROME</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>LEFT VENTRICULAR FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>ATRIAL FIBRILLATION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Erosive oesophagitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis chronic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Cytokine release syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Herpes zoster disseminated</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Oesophageal candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Pneumonia pseudomonal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>HERPES SIMPLEX</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Tumour lysis syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Myelodysplastic syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>LUNG ADENOCARCINOMA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>METASTATIC MALIGNANT MELANOMA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Pulmonary haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Renal stone removal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </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>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="49" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="49" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="48" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="30" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="17" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="28" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="17" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="24" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="32" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="23" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="23" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Catheter site pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="21" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="15" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Mass</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>OEDEMA PERIPHERAL</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>HYPOGAMMAGLOBULINAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Aspergillus infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Mycobacterium kansasii infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Perineal abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>SUBCUTANEOUS ABSCESS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>PNEUMONIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Periarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </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" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>COLON ADENOMA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Burning sensation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>COGNITIVE DISORDER</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hallucination</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Lung consolidation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Yellow skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </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/NCT02187861
org study id: BO29337
secondary id: 2014-000576-26
nct id: NCT02187861
lead sponsor: 
collaborator: 
This open-label, international, multicenter study will investigate the safety and efficacy of
      venetoclax (GDC-0199) in combination with bendamustine plus rituximab (venetoclax + BR)
      compared with BR alone in participants with relapsed and refractory fNHL, comparing two
      chemotherapy-containing regimens (Chemotherapy-Containing Cohort). In addition, an
      exploratory analysis of the safety and efficacy of venetoclax in combination with rituximab
      (venetoclax + rituximab), a chemotherapy-free regimen, will be performed (Chemotherapy-Free
      Cohort). Assignment to the Chemotherapy-Containing or Chemotherapy-Free Cohort will be
      decided at the discretion of the Investigator, unless one of the cohorts is not open to
      enrollment; in which case, participants may be enrolled only to the open cohort. The first 6
      participants enrolled in the Chemotherapy-Containing Cohort (or more if required) will
      comprise the Safety Run-In group for Treatment Arm B, dosing venetoclax at 600 milligrams
      (mg) in combination with BR. Once a dose has been chosen from the Safety Run-In Period,
      randomization to the two treatment arms of the Chemotherapy-Containing Cohort (Arms B and C)
      will begin.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Complete Metabolic Response (CMR) According to Independent Review Committee (IRC) as Per Lugano Classification, Using Positron Emission Tomography (PET) Scan at Primary Response Assessment (PRA)
time frame: 6-8 weeks after Cycle 6 Day 1 (PRA) (Cycle length = 28 days)
description: CMR: a score 1 (no uptake above background), 2 (uptake less than or equal to [<=] mediastinum), or 3 (uptake less than [<] mediastinum but <=liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites with no new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method.
measure: Percentage of Participants With CMR According to Investigator as Per Lugano Classification, Using PET Scan at PRA
time frame: 4-10 weeks after Cycle 6 Day 1 (Cycle length = 28 days)
description: CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (<mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.
measure: Percentage of Participants With CMR According to IRC as Per Lugano Classification, Using PET Scan at Year 1
time frame: 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)
description: CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (uptake <mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.
measure: Percentage of Participants With CMR According to Investigator as Per Lugano Classification, Using PET Scan at Year 1
time frame: 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)
description: CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (<mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.
measure: Percentage of Participants With Complete Response (CR) According to IRC as Per Lugano Classification, Using Computed Tomography (CT) Scan
time frame: 6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)
description: CR: defined as reduction of longest transverse diameter of lesion (LDi) of target nodes/nodal masses to <=1.5 centimeters (cm), and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/immunohistochemistry (IHC)-negative bone marrow morphology. Assessment was performed by an IRC according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.
measure: Percentage of Participants With CR According to Investigator as Per Lugano Classification, Using CT Scan
time frame: 4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)
description: CR: defined as reduction of LDi of target nodes/nodal masses to <=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. Assessment was performed by Investigator according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.
measure: Percentage of Participants With Objective Response (OR) According to IRC as Per Lugano Classification, Using PET Scan
time frame: 6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)
description: OR was defined as CMR or Partial Metabolic Response (PMR). CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (<mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. PMR: a score 4 (uptake moderately greater than [>] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.
measure: Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using PET Scan
time frame: 4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)
description: OR was defined as CMR or PMR. CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (<mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. PMR: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.
measure: Percentage of Participants With OR According to IRC as Per Lugano Classification, Using CT Scan
time frame: 6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)
description: OR was defined as CR or Partial Response (PR). CR: reduction of LDi of target nodes/nodal masses to <=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. PR: greater than or equal to (>=) 50 percent (%) decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen at least >50% beyond normal; and no new lesions. Assessment was performed by an IRC according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.
measure: Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using CT Scan
time frame: 4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)
description: OR was defined as CR or PR. CR: reduction of LDi of target nodes/nodal masses to <=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. PR: >=50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen at least >50% beyond normal; and no new lesions. Assessment was performed by Investigator according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.
measure: Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using PET or CT Scan
time frame: Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years)
description: OR was defined as CMR/CR or PMR/PR. CMR, CR, PMR, and PR have been defined in previous endpoints, and are not repeated here due to space constraint. Assessment was performed by Investigator according to Lugano classification using PET scan or CT scan (if PET is missing).
measure: Duration of Response (DOR) According to Investigator as Per Lugano Classification, Using PET or CT Scan
time frame: From CMR or PMR until disease progression or death due to any cause (assessed up to approximately 2.5 years)
description: DOR was defined as time from CMR/CR or PMR/PR until progressive disease (PD) or death due to any cause. CMR, CR, PMR, and PR have been defined in previous endpoints, and are not repeated here due to space constraint. PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan or CT scan (if PET is missing). DOR was calculated using Kaplan-Meier method.
measure: Percentage of Participants With Disease Progression (According to Investigator as Per Lugano Classification, Using PET or CT Scan) or Death
time frame: Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years)
description: PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan.
measure: Progression-Free Survival (PFS) According to Investigator as Per Lugano Classification, Using PET or CT Scan
time frame: Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years)
description: PFS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) until the date of disease progression, or death due to any cause. PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan. PFS was calculated using Kaplan-Meier method.
measure: Percentage of Participants With Disease Progression (According to Investigator as Per Lugano Classification, Using PET or CT Scan), Death, or Start of a New Anti-lymphoma Therapy
time frame: Baseline until disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first (assessed up to approximately 2.5 years)
description: PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan.
measure: Event-Free Survival (EFS) According to Investigator as Per Lugano Classification, Using PET or CT Scan
time frame: Baseline until disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first (assessed up to approximately 2.5 years)
description: EFS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) to the date of disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first. PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan. EFS was calculated using Kaplan-Meier method.
measure: Percentage of Participants Who Died Due to Any Cause
time frame: Baseline until death due to any cause (assessed up to approximately 2.5 years
measure: Overall Survival (OS)
time frame: Baseline until death due to any cause (assessed up to approximately 2.5 years)
description: OS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) to death due to any cause. For participants who are alive, OS was censored at the last contact. OS was calculated using Kaplan-Meier method.
measure: Apparent Clearance (CL) of Venetoclax
time frame: Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)
description: CL is a quantitative measure of the rate at which a drug substance is removed from the body.
measure: Apparent Volume of Distribution (Vd) of Venetoclax
time frame: Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)
description: Vd was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
measure: Time to Maximum Plasma Concentration (Tmax) of Venetoclax
time frame: Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)
measure: Maximum Plasma Concentration (Cmax) of Venetoclax
time frame: Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)
measure: Area Under the Plasma Concentration-Time Curve From Time 0 to Last Observed Concentration (AUClast) of Venetoclax
time frame: Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)
description: Area under the plasma concentration versus time curve from zero to the last measured concentration (AUClast).
measure: Area Under the Plasma Concentration-Time Curve From Time 0 to 8 Hours Post Dose (AUC0-8h) of Venetoclax
time frame: Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)
description: Area under the plasma concentration versus time curve from time 0 (pre-dose) to 8 hours post dose (AUC0-8h).
arm group label: Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)
arm group type: Experimental
description: Participants will receive venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in will continue until first 9 participants complete the safety observation window of 28 days. Participants will continue receiving the same treatment as decided for Arm B.
arm group label: Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)
arm group type: Experimental
description: Participants will receive venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle will be of 28 days.
arm group label: Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)
arm group type: Experimental
description: Participants will receive venetoclax at doses decided from safety run-in orally once daily continuously for 1 year along with rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
arm group label: Chemotherapy-Containing Cohort: Arm C (BR)
arm group type: Active Comparator
description: Participants will receive rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
intervention type: Drug
intervention name: Venetoclax
description: Venetoclax will be administered as per the schedule specified under arm description.
arm group label: Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)
arm group label: Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)
arm group label: Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)
other name: GDC-0199
other name: ABT-199
intervention type: Drug
intervention name: Bendamustine
description: Bendamustine will be administered as per the schedule specified under arm description.
arm group label: Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)
arm group label: Chemotherapy-Containing Cohort: Arm C (BR)
arm group label: Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)
other name: Levact
intervention type: Drug
intervention name: Rituximab
description: Rituximab will be administered as per the schedule specified under arm description.
arm group label: Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)
arm group label: Chemotherapy-Containing Cohort: Arm C (BR)
arm group label: Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)
arm group label: Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)
other name: MabThera
other name: Rituxan
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
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country: Australia
country: Belgium
country: Canada
country: France
country: Germany
country: Italy
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Follicular
mesh term: Lymphoma, Non-Hodgkin
mesh term: Rituximab
mesh term: Venetoclax
mesh term: Bendamustine Hydrochloride
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