<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01724021</url>
  </required_header>
  <id_info>
    <org_study_id>MO28457</org_study_id>
    <secondary_id>2012-003230-17</secondary_id>
    <nct_id>NCT01724021</nct_id>
  </id_info>
  <brief_title>A Study of Participant Preference With Subcutaneous Versus Intravenous MabThera/Rituxan in Participants With CD20+ Diffuse Large B-Cell Lymphoma or CD20+ Follicular Non-Hodgkin's Lymphoma Grades 1, 2 or 3a</brief_title>
  <official_title>A Randomized, Open-label, Mutli-centre Study to Evaluate Patient Preference With Subcutaneous Administration of Rituximab Versus Intravenous Rituximab in Previously Untreated Patients With CD20+ Diffuse Large B-cell Lymphoma or CD20+ Follicular Non-Hodgkin's Lymphoma Grades 1, 2, OR 3A</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This multi-center, open-label, randomized study will evaluate the participant preference with&#xD;
      subcutaneous versus intravenous administration of MabThera/Rituxan (rituximab) in&#xD;
      participants with CD20+ diffuse large B-cell lymphoma or CD20+ follicular non-Hodgkin's&#xD;
      lymphoma. In Arm A, participants will receive MabThera/Rituxan 375 mg/m2 intravenously (IV)&#xD;
      on Day 1 of Cycle 1 and MabThera/Rituxan 1400 mg subcutaneously (SC) on Day 1 of Cycles 2-4,&#xD;
      followed by MabThera/Rituxan IV in Cycles 5-8. Participants in Arm B will receive&#xD;
      MabThera/Rituxan IV in Cycles 1-4 and SC in Cycles 5-8. All participants will receive 6-8&#xD;
      cycles of standard chemotherapy (according to local country practice) with 8 cycles of&#xD;
      MabThera/Rituxan. Anticipated time on study treatment is up to 24 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6</measure>
    <time_frame>Cycle 6 (Up to 24 weeks)</time_frame>
    <description>Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing cycle 6.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8</measure>
    <time_frame>Cycle 8 (Up to 32 weeks)</time_frame>
    <description>Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing Cycle 8.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment Emergent Adverse Events (AEs)</measure>
    <time_frame>Randomization of first participant to clinical cutoff date (Up to 4 years)</time_frame>
    <description>An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV])</measure>
    <time_frame>Cycle 1-4, Cycle 5-8 for both SC and IV (Up to 32 weeks)</time_frame>
    <description>Administration time was defined as the time from start to end of the SC injection or from start to end of the IV infusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer Therapy Satisfaction Questionnaire (CTSQ) Score</measure>
    <time_frame>During Cycle 4, 8 of treatment (Up to 32 weeks)</time_frame>
    <description>CTSQ is a validated 16-item questionnaire that measures three domains related to participants' satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rituximab Administration Satisfaction Questionnaire (RASQ) Score</measure>
    <time_frame>During Cycle 4, 8 of treatment (Up to 32 weeks)</time_frame>
    <description>The RASQ is a 20-item questionnaire that measures five domains related to the impact of treatment administration. These include physical impact, psychological impact, impact on activities of daily living (ADLs), convenience, and satisfaction. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Response (CR) Rate</measure>
    <time_frame>28 days (± 3 days) after Day 1 of the last dose of induction treatment</time_frame>
    <description>CR rate was assessed according to the International Working Group (IWG) Response Criteria (CHESON ET AL. 1999) and included CR and CR unconfirmed (CRu). CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by &gt; 75 % but still &gt;1.5 cm in size, and indeterminate bone marrow assessment. Tumor assessments were based on computed tomography (CT) scans with contrast of the neck, chest, and abdomen (if detectable by these techniques) or other diagnostic means, if applicable. Other methods (e.g., MRI) were acceptable for participants in whom contrast CT scans were contraindicated. Due to the limited availability of FDG-PET scanners, an FDG-PET scan was not mandated in the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event-free Survival (EFS)</measure>
    <time_frame>From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)</time_frame>
    <description>EFS was defined as the time from randomization to first occurrence of progression or relapse according to IWG response criteria. IWG criteria is defined using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; partial response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses; stable disease (SD): participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for progressive disease (PD); PD: Lymph nodes considered abnormal if the long axis is more than 1.5 centimeter (cm) regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes less than or equal to (&lt;=) 1.0 × &lt;= 1.0 cm would not be considered as abnormal for PD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free Survival (DFS)</measure>
    <time_frame>From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)</time_frame>
    <description>DFS was defined as the period from the data of the initial CR/CRu until the date of relapse or death from any cause, whichever occurred first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival (PFS)</measure>
    <time_frame>From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)</time_frame>
    <description>PFS was defined as the time from randomization to the first occurrence of progression or relapse, according to the IWG response criteria. IWG criteria is defined criteria using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; PR: At least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses; SD: participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for PD; PD: Lymph nodes considered abnormal if the long axis is more than 1.5 cm regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes &lt;= 1.0 × &lt;= 1.0 cm would not be considered as abnormal for PD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)</time_frame>
    <description>OS was defined as the time from randomization to death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Anti-Rituximab Antibodies Over Time</measure>
    <time_frame>Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time</measure>
    <time_frame>Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Summary of Observed Serum Rituximab Concentration</measure>
    <time_frame>Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">743</enrollment>
  <condition>Diffuse Large B-Cell Lymphoma, Non-Hodgkin's Lymphoma</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP)</intervention_name>
    <description>Standard chemotherapy</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)</intervention_name>
    <description>Standard chemotherapy</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bendamustine</intervention_name>
    <description>Standard chemotherapy</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
    <other_name>Treanda</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>1400 mg subcutaneously (SC), Day 1 Cycles 2-4</description>
    <arm_group_label>Arm A</arm_group_label>
    <other_name>Rituxan</other_name>
    <other_name>MabThera</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>375 mg/m2 IV, Day 1 Cycles 1-4</description>
    <arm_group_label>Arm B</arm_group_label>
    <other_name>Rituxan</other_name>
    <other_name>MabThera</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>375 mg/m2 intravenously (IV), Day 1 Cycles 1 and 4-8</description>
    <arm_group_label>Arm A</arm_group_label>
    <other_name>Rituxan</other_name>
    <other_name>MabThera</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>1400 mg SC, Day 1 Cycles 5-8</description>
    <arm_group_label>Arm B</arm_group_label>
    <other_name>Rituxan</other_name>
    <other_name>MabThera</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult participants , &gt;/= 18 and &lt;/= 80 years of age&#xD;
&#xD;
          -  Histologically confirmed, previously untreated CD20+ diffuse large B-cell lymphoma&#xD;
             (DLBCL) or CD20+ follicular non-Hodgkin's lymphoma (NHL) Grade 1, 2, or 3a, according&#xD;
             to World Health Organization (WHO) classification&#xD;
&#xD;
          -  An International Prognostic Index (IPI) score of 1-4 or IPI score of 0 with bulky&#xD;
             disease, defined as one lesion &gt;/= 7.5 cm, or Follicular Lymphoma International&#xD;
             Prognostic Index (FLIPI; low, intermediate or high risk)&#xD;
&#xD;
          -  At least one bi-dimensionally measurable lesion defined as &gt;/=1.5 cm in its largest&#xD;
             dimension on CT scan&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status &lt;/= 3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Transformed lymphoma or follicular lymphoma IIIB&#xD;
&#xD;
          -  Primary central nervous system (CNS) lymphoma, histologic evidence of transformation&#xD;
             to Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, primary&#xD;
             cutaneous DLBCL, or primary DLBCL of the testis&#xD;
&#xD;
          -  History of other malignancy that could affect compliance with the protocol or&#xD;
             interpretation of the results; this includes a malignancy that has been treated but&#xD;
             not with curative intent, unless the malignancy has been in remission for &gt;/= 5 years&#xD;
             prior to enrolment; participants with a history of curatively treated basal or&#xD;
             squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix are&#xD;
             eligible&#xD;
&#xD;
          -  Prior therapy for DLBCL or NHL, with the exception of nodal biopsy or local&#xD;
             irradiation&#xD;
&#xD;
          -  Prior treatment with cytotoxic drugs (with the exclusion of intrathecal methotrexate&#xD;
             for CNS prophylaxis in DLBCL) or rituximab for another condition, or prior use of an&#xD;
             anti-CD20 drug&#xD;
&#xD;
          -  Prior use of monoclonal antibody within 3 months prior to randomization&#xD;
&#xD;
          -  Chemotherapy or other investigational therapy within 28 days prior to randomization&#xD;
&#xD;
          -  Ongoing corticosteroid use &gt; 30 mg/day prednisolone or equivalent&#xD;
&#xD;
          -  Inadequate renal. hematologic or hepatic function&#xD;
&#xD;
          -  Active and/or severe infection or any major episode of infection within 4 weeks prior&#xD;
             to randomization&#xD;
&#xD;
          -  Active hepatitis B virus or active hepatitis C virus infection&#xD;
&#xD;
          -  History of human immunodeficiency (HIV) seropositive status&#xD;
&#xD;
          -  A positive pregnancy test in women of childbearing potential&#xD;
&#xD;
          -  Life expectancy of less than 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</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>
      <address>
        <city>Buenos Aires</city>
        <zip>1425</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Corrientes</city>
        <zip>3400</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santa Fé</city>
        <zip>3000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Canberra</city>
        <state>Australian Capital Territory</state>
        <zip>2605</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Camperdown</city>
        <state>New South Wales</state>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Liverpool</city>
        <state>New South Wales</state>
        <zip>2170</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Randwick</city>
        <state>New South Wales</state>
        <zip>2031</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brisbane</city>
        <state>Queensland</state>
        <zip>4101</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hobart</city>
        <state>Tasmania</state>
        <zip>7000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Geelong</city>
        <state>Victoria</state>
        <zip>3220</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Malvern</city>
        <state>Victoria</state>
        <zip>3144</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wodonga</city>
        <state>Victoria</state>
        <zip>3690</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Perth</city>
        <state>Western Australia</state>
        <zip>6000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Krems</city>
        <zip>3500</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Linz</city>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Steyr</city>
        <zip>4400</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wien</city>
        <zip>1140</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Belo Horizonte</city>
        <state>MG</state>
        <zip>30150-320</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Juiz de Fora</city>
        <state>MG</state>
        <zip>36010-510</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Varginha</city>
        <state>MG</state>
        <zip>37062-770</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Recife</city>
        <state>PE</state>
        <zip>50070-550</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Curitiba</city>
        <state>PR</state>
        <zip>81520-060</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Londrina</city>
        <state>PR</state>
        <zip>86050-190</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Caxias do Sul</city>
        <state>RS</state>
        <zip>95070-560</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Novo Hamburgo</city>
        <state>RS</state>
        <zip>93510-250</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santa Maria</city>
        <state>RS</state>
        <zip>97015-373</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santo Andre</city>
        <state>SP</state>
        <zip>09060-650</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sao Jose do Rio Preto</city>
        <state>SP</state>
        <zip>15090-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Burnaby</city>
        <state>British Columbia</state>
        <zip>V5G 2X6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6Z 1Y6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <zip>V8R 6V5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
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    </facility>
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  <location>
    <facility>
      <address>
        <city>Guatemala</city>
        <zip>01010</zip>
        <country>Guatemala</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hong Kong</city>
        <zip>852</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Budapest</city>
        <zip>1097</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gyor</city>
        <zip>9024</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gyula</city>
        <zip>5700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kaposvar</city>
        <zip>7400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nyíregyháza</city>
        <zip>4400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Szeged</city>
        <zip>6720</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Szolnok</city>
        <zip>5004</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bandung</city>
        <zip>40161</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jakarta</city>
        <zip>11420</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jogjakarta</city>
        <zip>55284</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Surabaya</city>
        <zip>60111</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Catanzaro</city>
        <state>Calabria</state>
        <zip>88100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ferrara</city>
        <state>Emilia-Romagna</state>
        <zip>44100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Parma</city>
        <state>Emilia-Romagna</state>
        <zip>43126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Piacenza</city>
        <state>Emilia-Romagna</state>
        <zip>29121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Candiolo</city>
        <state>Piemonte</state>
        <zip>10060</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cuneo</city>
        <state>Piemonte</state>
        <zip>12100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brindisi</city>
        <state>Puglia</state>
        <zip>72100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lecce</city>
        <state>Puglia</state>
        <zip>73100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Palermo</city>
        <state>Sicilia</state>
        <zip>90146</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lido Di Camaiore</city>
        <state>Toscana</state>
        <zip>55041</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Livorno</city>
        <state>Toscana</state>
        <zip>57124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Busan</city>
        <zip>602-739</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Daegu</city>
        <zip>41944</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seoul</city>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ampang</city>
        <zip>68000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kuala Lumpur</city>
        <zip>56000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kuching</city>
        <zip>93586</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sabah</city>
        <zip>88586</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Amstelveen</city>
        <zip>1186 AH</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Amsterdam</city>
        <zip>1091 AC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Apeldoorn</city>
        <zip>7334 DZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Beverwijk</city>
        <zip>1942 LE</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Capelle Aan De Yssel</city>
        <zip>2906 ZC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Delftzijl</city>
        <zip>9934 JD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Den Haag</city>
        <zip>2512 VA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Den Haag</city>
        <zip>2566 MJ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Eindhoven</city>
        <zip>5623 EJ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Goes</city>
        <zip>4462 RA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Leidschendam</city>
        <zip>2262 BA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rotterdam</city>
        <zip>3045 PM</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tilburg</city>
        <zip>5022 GC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Utrecht</city>
        <zip>3582 KE</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Auckland</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Panama City</city>
        <zip>0832-00752</zip>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Panama</city>
        <zip>080814</zip>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Panama</city>
        <zip>0834-02723</zip>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Arequipa</city>
        <zip>04001</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cusco</city>
        <zip>08006</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>La Victoria, Lima</city>
        <zip>Lima 13</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cebu City</city>
        <zip>6000</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Manila</city>
        <zip>1000</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Manila</city>
        <zip>1003</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Quezon City</city>
        <zip>1100</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lisboa</city>
        <zip>1449-005</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Matosinhos</city>
        <zip>4454-509</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ponta Delgada</city>
        <zip>9500-370</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Setubal</city>
        <zip>2910-446</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Viseu</city>
        <zip>3504-509</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Baia Mare</city>
        <zip>430031</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brasov</city>
        <zip>500152</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brasov</city>
        <zip>500326</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bucharest</city>
        <zip>022328</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bucharest</city>
        <zip>050098</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bucuresti</city>
        <zip>030171</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400015</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Craiova</city>
        <zip>200143</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Iasi</city>
        <zip>700483</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sibiu</city>
        <zip>550245</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Timisoara</city>
        <zip>300239</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Falun</city>
        <zip>79182</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Göteborg</city>
        <zip>S-413 45</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jönköping</city>
        <zip>551_85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Karlstad</city>
        <zip>65185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sundsvall</city>
        <zip>85186</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Västerås</city>
        <zip>SE-71 289</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kaohsung</city>
        <zip>883</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Taichung</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bangkok</city>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chiang Mai</city>
        <zip>50200</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Khon Kaen</city>
        <zip>40002</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ankara</city>
        <zip>06200</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Denizli</city>
        <zip>20070</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Erzurum</city>
        <zip>25050</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Malatya</city>
        <zip>44280</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ha Noi</city>
        <zip>70000</zip>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hochiminh city</city>
        <zip>70000</zip>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Austria</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>Colombia</country>
    <country>Croatia</country>
    <country>Denmark</country>
    <country>Dominican Republic</country>
    <country>Egypt</country>
    <country>El Salvador</country>
    <country>Germany</country>
    <country>Guatemala</country>
    <country>Hong Kong</country>
    <country>Hungary</country>
    <country>Indonesia</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Malaysia</country>
    <country>Netherlands</country>
    <country>New Zealand</country>
    <country>Panama</country>
    <country>Peru</country>
    <country>Philippines</country>
    <country>Portugal</country>
    <country>Romania</country>
    <country>Sweden</country>
    <country>Taiwan</country>
    <country>Thailand</country>
    <country>Turkey</country>
    <country>Vietnam</country>
  </location_countries>
  <removed_countries>
    <country>Belgium</country>
    <country>Switzerland</country>
  </removed_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</study_first_posted>
  <results_first_submitted>May 3, 2016</results_first_submitted>
  <results_first_submitted_qc>July 19, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 29, 2016</results_first_posted>
  <last_update_submitted>December 19, 2017</last_update_submitted>
  <last_update_submitted_qc>December 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2018</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, Non-Hodgkin</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
    <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
    <mesh_term>Lymphoma, Follicular</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Prednisolone</mesh_term>
    <mesh_term>Methylprednisolone Acetate</mesh_term>
    <mesh_term>Methylprednisolone</mesh_term>
    <mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
    <mesh_term>Prednisolone acetate</mesh_term>
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Bendamustine Hydrochloride</mesh_term>
    <mesh_term>Rituximab</mesh_term>
    <mesh_term>Vincristine</mesh_term>
    <mesh_term>Doxorubicin</mesh_term>
    <mesh_term>Liposomal doxorubicin</mesh_term>
    <mesh_term>Prednisolone hemisuccinate</mesh_term>
    <mesh_term>Prednisolone phosphate</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 743 participants were enrolled across all the sites and were included in the intent to treat (ITT) population. Three participants were enrolled but died prior to receiving study medication and were not included in the safety population. The Participant Flow represents the safety population.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Arm A</title>
          <description>Participants in Arm A received one cycle of rituximab 375 milligram per metre square (mg/m^2) intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
        </group>
        <group group_id="P2">
          <title>Arm B</title>
          <description>Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="371"/>
                <participants group_id="P2" count="369"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="244"/>
                <participants group_id="P2" count="236"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="127"/>
                <participants group_id="P2" count="133"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="58"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant request/ Withdrew consent</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Reason Not Specified</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="39"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Missing</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Arm A</title>
          <description>Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
        </group>
        <group group_id="B2">
          <title>Arm B</title>
          <description>Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="371"/>
            <count group_id="B2" value="369"/>
            <count group_id="B3" value="740"/>
          </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="58.2" spread="13.18"/>
                    <measurement group_id="B2" value="59.4" spread="12.64"/>
                    <measurement group_id="B3" value="58.8" spread="12.92"/>
                  </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="187"/>
                    <measurement group_id="B2" value="180"/>
                    <measurement group_id="B3" value="367"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="184"/>
                    <measurement group_id="B2" value="189"/>
                    <measurement group_id="B3" value="373"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6</title>
        <description>Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing cycle 6.</description>
        <time_frame>Cycle 6 (Up to 24 weeks)</time_frame>
        <population>ITT population included all participants who were randomized in the study. Number of participants analyzed specifies number of participants who were evaluable for the outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A</title>
            <description>Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Arm B</title>
            <description>Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6</title>
          <description>Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing cycle 6.</description>
          <population>ITT population included all participants who were randomized in the study. Number of participants analyzed specifies number of participants who were evaluable for the 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="372"/>
                <count group_id="O2" value="371"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.1" lower_limit="74.2" upper_limit="83.5"/>
                    <measurement group_id="O2" value="80.6" lower_limit="75.7" upper_limit="84.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8</title>
        <description>Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing Cycle 8.</description>
        <time_frame>Cycle 8 (Up to 32 weeks)</time_frame>
        <population>ITT population included all participants who were randomized in the study. Number of participants analyzed specifies number of participants who were evaluable for the outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A</title>
            <description>Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Arm B</title>
            <description>Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8</title>
          <description>Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing Cycle 8.</description>
          <population>ITT population included all participants who were randomized in the study. Number of participants analyzed specifies number of participants who were evaluable for the 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="372"/>
                <count group_id="O2" value="371"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.1" lower_limit="71.9" upper_limit="81.8"/>
                    <measurement group_id="O2" value="84.2" lower_limit="79.6" upper_limit="88.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment Emergent Adverse Events (AEs)</title>
        <description>An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.</description>
        <time_frame>Randomization of first participant to clinical cutoff date (Up to 4 years)</time_frame>
        <population>The safety population included all participants who received at least one dose of rituximab. Number of participants analyzed specifies number of participants who were evaluable for the outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A</title>
            <description>Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Arm B</title>
            <description>Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Adverse Events (AEs)</title>
          <description>An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.</description>
          <population>The safety population included all participants who received at least one dose of rituximab. Number of participants analyzed specifies number of participants who were evaluable for the outcome measure.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="371"/>
                <count group_id="O2" value="369"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="352"/>
                    <measurement group_id="O2" value="347"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV])</title>
        <description>Administration time was defined as the time from start to end of the SC injection or from start to end of the IV infusion</description>
        <time_frame>Cycle 1-4, Cycle 5-8 for both SC and IV (Up to 32 weeks)</time_frame>
        <population>ITT population included all participants who were randomized in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab Intravenous (IV)</title>
            <description>Rituximab was administered at a dose of 375 mg/m2 body surface area (BSA) as a single IV infusion, followed by administration of chemotherapy. At Cycle 1, Day 1, the first rituximab dose for both Arms A and B was always administered as a slow IV infusion, according to local standard practice. Faster infusion rates were permitted after Cycle 1, according to local practice. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Rituximab Subcutaneous (SC)</title>
            <description>Each treatment cycle consisted of a single SC injection of rituximab administered at a fixed dose of 1400 mg. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV])</title>
          <description>Administration time was defined as the time from start to end of the SC injection or from start to end of the IV infusion</description>
          <population>ITT population included all participants who were randomized in the study.</population>
          <units>minutes</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="740"/>
                <count group_id="O2" value="687"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="840" lower_limit="0" upper_limit="3967.0"/>
                    <measurement group_id="O2" value="22" lower_limit="0" upper_limit="1242.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cancer Therapy Satisfaction Questionnaire (CTSQ) Score</title>
        <description>CTSQ is a validated 16-item questionnaire that measures three domains related to participants' satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.</description>
        <time_frame>During Cycle 4, 8 of treatment (Up to 32 weeks)</time_frame>
        <population>ITT population included all participants who were randomized in the study. Here, &quot;Number Analyzed&quot; represents the number of participants who were evaluable at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab Intravenous (IV)</title>
            <description>Rituximab was administered at a dose of 375 mg/m2 body surface area (BSA) as a single IV infusion, followed by administration of chemotherapy. At Cycle 1, Day 1, the first rituximab dose for both Arms A and B was always administered as a slow IV infusion, according to local standard practice. Faster infusion rates were permitted after Cycle 1, according to local practice. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Rituximab Subcutaneous (SC)</title>
            <description>Each treatment cycle consisted of a single SC injection of rituximab administered at a fixed dose of 1400 mg. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Cancer Therapy Satisfaction Questionnaire (CTSQ) Score</title>
          <description>CTSQ is a validated 16-item questionnaire that measures three domains related to participants' satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.</description>
          <population>ITT population included all participants who were randomized in the study. Here, &quot;Number Analyzed&quot; represents the number of participants who were evaluable at specified time points.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="740"/>
                <count group_id="O2" value="687"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Expectations of therapy domain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="631"/>
                    <count group_id="O2" value="627"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.88" spread="18.315"/>
                    <measurement group_id="O2" value="82.07" spread="17.817"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Feelings about side effects domain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="630"/>
                    <count group_id="O2" value="624"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.63" spread="22.316"/>
                    <measurement group_id="O2" value="61.64" spread="22.324"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Satisfaction with therapy domain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="619"/>
                    <count group_id="O2" value="623"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.59" spread="12.218"/>
                    <measurement group_id="O2" value="85.42" spread="11.259"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rituximab Administration Satisfaction Questionnaire (RASQ) Score</title>
        <description>The RASQ is a 20-item questionnaire that measures five domains related to the impact of treatment administration. These include physical impact, psychological impact, impact on activities of daily living (ADLs), convenience, and satisfaction. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.</description>
        <time_frame>During Cycle 4, 8 of treatment (Up to 32 weeks)</time_frame>
        <population>ITT population included all participants who were randomized in the study. Here, &quot;Number Analyzed&quot; represents the number of participants who were evaluable at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab Intravenous (IV)</title>
            <description>Rituximab was administered at a dose of 375 mg/m2 body surface area (BSA) as a single IV infusion, followed by administration of chemotherapy. At Cycle 1, Day 1, the first rituximab dose for both Arms A and B was always administered as a slow IV infusion, according to local standard practice. Faster infusion rates were permitted after Cycle 1, according to local practice. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Rituximab Subcutaneous (SC)</title>
            <description>Each treatment cycle consisted of a single SC injection of rituximab administered at a fixed dose of 1400 mg. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Rituximab Administration Satisfaction Questionnaire (RASQ) Score</title>
          <description>The RASQ is a 20-item questionnaire that measures five domains related to the impact of treatment administration. These include physical impact, psychological impact, impact on activities of daily living (ADLs), convenience, and satisfaction. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.</description>
          <population>ITT population included all participants who were randomized in the study. Here, &quot;Number Analyzed&quot; represents the number of participants who were evaluable at specified time points.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="740"/>
                <count group_id="O2" value="687"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical impact domain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="622"/>
                    <count group_id="O2" value="618"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.14" spread="15.629"/>
                    <measurement group_id="O2" value="82.08" spread="15.882"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Psychological Impact domain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="614"/>
                    <count group_id="O2" value="612"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.73" spread="16.377"/>
                    <measurement group_id="O2" value="84.00" spread="14.358"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Impact on activitiesf daily living</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="604"/>
                    <count group_id="O2" value="600"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.49" spread="22.233"/>
                    <measurement group_id="O2" value="81.86" spread="15.844"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Convenience domain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="620"/>
                    <count group_id="O2" value="599"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.05" spread="20.757"/>
                    <measurement group_id="O2" value="81.05" spread="13.088"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Satisfaction domain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="617"/>
                    <count group_id="O2" value="624"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.88" spread="19.349"/>
                    <measurement group_id="O2" value="87.26" spread="14.972"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Complete Response (CR) Rate</title>
        <description>CR rate was assessed according to the International Working Group (IWG) Response Criteria (CHESON ET AL. 1999) and included CR and CR unconfirmed (CRu). CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by &gt; 75 % but still &gt;1.5 cm in size, and indeterminate bone marrow assessment. Tumor assessments were based on computed tomography (CT) scans with contrast of the neck, chest, and abdomen (if detectable by these techniques) or other diagnostic means, if applicable. Other methods (e.g., MRI) were acceptable for participants in whom contrast CT scans were contraindicated. Due to the limited availability of FDG-PET scanners, an FDG-PET scan was not mandated in the study.</description>
        <time_frame>28 days (± 3 days) after Day 1 of the last dose of induction treatment</time_frame>
        <population>ITT population included all participants who were randomized in the study. Number of participants analyzed specifies number of participants who were evaluable for the outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A</title>
            <description>Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Arm B</title>
            <description>Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Complete Response (CR) Rate</title>
          <description>CR rate was assessed according to the International Working Group (IWG) Response Criteria (CHESON ET AL. 1999) and included CR and CR unconfirmed (CRu). CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by &gt; 75 % but still &gt;1.5 cm in size, and indeterminate bone marrow assessment. Tumor assessments were based on computed tomography (CT) scans with contrast of the neck, chest, and abdomen (if detectable by these techniques) or other diagnostic means, if applicable. Other methods (e.g., MRI) were acceptable for participants in whom contrast CT scans were contraindicated. Due to the limited availability of FDG-PET scanners, an FDG-PET scan was not mandated in the study.</description>
          <population>ITT population included all participants who were randomized in the study. Number of participants analyzed specifies number of participants who were evaluable for the 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="307"/>
                <count group_id="O2" value="315"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.2" lower_limit="43.5" upper_limit="54.9"/>
                    <measurement group_id="O2" value="52.7" lower_limit="47.0" upper_limit="58.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Event-free Survival (EFS)</title>
        <description>EFS was defined as the time from randomization to first occurrence of progression or relapse according to IWG response criteria. IWG criteria is defined using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; partial response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses; stable disease (SD): participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for progressive disease (PD); PD: Lymph nodes considered abnormal if the long axis is more than 1.5 centimeter (cm) regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes less than or equal to (&lt;=) 1.0 × &lt;= 1.0 cm would not be considered as abnormal for PD.</description>
        <time_frame>From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)</time_frame>
        <population>ITT population included all participants who were randomized in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A</title>
            <description>Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Arm B</title>
            <description>Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Event-free Survival (EFS)</title>
          <description>EFS was defined as the time from randomization to first occurrence of progression or relapse according to IWG response criteria. IWG criteria is defined using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; partial response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses; stable disease (SD): participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for progressive disease (PD); PD: Lymph nodes considered abnormal if the long axis is more than 1.5 centimeter (cm) regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes less than or equal to (&lt;=) 1.0 × &lt;= 1.0 cm would not be considered as abnormal for PD.</description>
          <population>ITT population included all participants who were randomized in the study.</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="372"/>
                <count group_id="O2" value="371"/>
              </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 it's CI) was not reached for this Outcome Measure.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Median (and it's CI) was not reached for this Outcome Measure.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease-free Survival (DFS)</title>
        <description>DFS was defined as the period from the data of the initial CR/CRu until the date of relapse or death from any cause, whichever occurred first.</description>
        <time_frame>From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)</time_frame>
        <population>ITT population included all participants who were randomized in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A</title>
            <description>Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Arm B</title>
            <description>Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Disease-free Survival (DFS)</title>
          <description>DFS was defined as the period from the data of the initial CR/CRu until the date of relapse or death from any cause, whichever occurred first.</description>
          <population>ITT population included all participants who were randomized in the study.</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="372"/>
                <count group_id="O2" value="371"/>
              </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 it's CI) was not reached for this Outcome Measure.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Median (and it's CI) was not reached for this Outcome Measure.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-free Survival (PFS)</title>
        <description>PFS was defined as the time from randomization to the first occurrence of progression or relapse, according to the IWG response criteria. IWG criteria is defined criteria using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; PR: At least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses; SD: participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for PD; PD: Lymph nodes considered abnormal if the long axis is more than 1.5 cm regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes &lt;= 1.0 × &lt;= 1.0 cm would not be considered as abnormal for PD.</description>
        <time_frame>From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)</time_frame>
        <population>ITT population included all participants who were randomized in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A</title>
            <description>Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Arm B</title>
            <description>Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival (PFS)</title>
          <description>PFS was defined as the time from randomization to the first occurrence of progression or relapse, according to the IWG response criteria. IWG criteria is defined criteria using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; PR: At least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses; SD: participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for PD; PD: Lymph nodes considered abnormal if the long axis is more than 1.5 cm regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes &lt;= 1.0 × &lt;= 1.0 cm would not be considered as abnormal for PD.</description>
          <population>ITT population included all participants who were randomized in the study.</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="372"/>
                <count group_id="O2" value="371"/>
              </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 it's CI) was not reached for this Outcome Measure.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Median (and it's CI) was not reached for this Outcome Measure.</measurement>
                  </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 time from randomization to death from any cause.</description>
        <time_frame>From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)</time_frame>
        <population>ITT population included all participants who were randomized in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A</title>
            <description>Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Arm B</title>
            <description>Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>OS was defined as the time from randomization to death from any cause.</description>
          <population>ITT population included all participants who were randomized in the study.</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="372"/>
                <count group_id="O2" value="371"/>
              </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 it's CI) was not reached for this Outcome Measure.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Median (and it's CI) was not reached for this Outcome Measure.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Anti-Rituximab Antibodies Over Time</title>
        <time_frame>Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)</time_frame>
        <population>The safety population included all participants who received at least one dose of rituximab. Here, &quot;Number Analyzed&quot; represents the number of participants who were evaluable at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A</title>
            <description>Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Arm B</title>
            <description>Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Anti-Rituximab Antibodies Over Time</title>
          <population>The safety population included all participants who received at least one dose of rituximab. Here, &quot;Number Analyzed&quot; represents the number of participants who were evaluable at specified time points.</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="371"/>
                <count group_id="O2" value="369"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="342"/>
                    <count group_id="O2" value="335"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0"/>
                    <measurement group_id="O2" value="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="333"/>
                    <count group_id="O2" value="325"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1"/>
                    <measurement group_id="O2" value="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="328"/>
                    <count group_id="O2" value="322"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3"/>
                    <measurement group_id="O2" value="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="323"/>
                    <count group_id="O2" value="323"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interim staging</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="283"/>
                    <count group_id="O2" value="281"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="237"/>
                    <count group_id="O2" value="253"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="300"/>
                    <count group_id="O2" value="289"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="288"/>
                    <count group_id="O2" value="290"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="281"/>
                    <count group_id="O2" value="283"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Final staging</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="261"/>
                    <count group_id="O2" value="260"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up, 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="166"/>
                    <count group_id="O2" value="183"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up, 12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="141"/>
                    <count group_id="O2" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1"/>
                    <measurement group_id="O2" value="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of study/early treatment termination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6"/>
                    <measurement group_id="O2" value="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time</title>
        <time_frame>Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)</time_frame>
        <population>The safety population included all participants who received at least one dose of rituximab. Here, &quot;Number Analyzed&quot; represents the number of participants who were evaluable at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A</title>
            <description>Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Arm B</title>
            <description>Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time</title>
          <population>The safety population included all participants who received at least one dose of rituximab. Here, &quot;Number Analyzed&quot; represents the number of participants who were evaluable at specified time points.</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="371"/>
                <count group_id="O2" value="369"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4"/>
                    <measurement group_id="O2" value="15.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="342"/>
                    <count group_id="O2" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0"/>
                    <measurement group_id="O2" value="18.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="339"/>
                    <count group_id="O2" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1"/>
                    <measurement group_id="O2" value="23.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="327"/>
                    <count group_id="O2" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0"/>
                    <measurement group_id="O2" value="14.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interim staging</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="279"/>
                    <count group_id="O2" value="269"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0"/>
                    <measurement group_id="O2" value="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="266"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5"/>
                    <measurement group_id="O2" value="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="303"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.0"/>
                    <measurement group_id="O2" value="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="303"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.8"/>
                    <measurement group_id="O2" value="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="291"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.3"/>
                    <measurement group_id="O2" value="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Final staging</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="240"/>
                    <count group_id="O2" value="261"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0"/>
                    <measurement group_id="O2" value="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up, 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="155"/>
                    <count group_id="O2" value="172"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5"/>
                    <measurement group_id="O2" value="13.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up, 12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="142"/>
                    <count group_id="O2" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7"/>
                    <measurement group_id="O2" value="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of study/early treatment termination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="171"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5"/>
                    <measurement group_id="O2" value="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Summary of Observed Serum Rituximab Concentration</title>
        <time_frame>Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)</time_frame>
        <population>The safety population included all participants who received at least one dose of rituximab. Here, &quot;Number Analyzed&quot; represents the number of participants who were evaluable at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A</title>
            <description>Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Arm B</title>
            <description>Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Summary of Observed Serum Rituximab Concentration</title>
          <population>The safety population included all participants who received at least one dose of rituximab. Here, &quot;Number Analyzed&quot; represents the number of participants who were evaluable at specified time points.</population>
          <units>microgram per milliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="371"/>
                <count group_id="O2" value="369"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="285"/>
                    <count group_id="O2" value="281"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3355.9" spread="21600.95"/>
                    <measurement group_id="O2" value="970.1" spread="9415.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="284"/>
                    <count group_id="O2" value="280"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25053.1" spread="19590.17"/>
                    <measurement group_id="O2" value="24541.1" spread="18141.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="281"/>
                    <count group_id="O2" value="281"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62977.0" spread="30037.98"/>
                    <measurement group_id="O2" value="46093.9" spread="31214.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="282"/>
                    <count group_id="O2" value="285"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87956.6" spread="40441.84"/>
                    <measurement group_id="O2" value="59485.5" spread="29183.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interim staging</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="256"/>
                    <count group_id="O2" value="251"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117273.6" spread="52227.06"/>
                    <measurement group_id="O2" value="77665.3" spread="29161.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="212"/>
                    <count group_id="O2" value="226"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108030.9" spread="54335.08"/>
                    <measurement group_id="O2" value="70387.3" spread="30256.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="282"/>
                    <count group_id="O2" value="266"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100927.7" spread="49287.42"/>
                    <measurement group_id="O2" value="98679.7" spread="40001.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="272"/>
                    <count group_id="O2" value="268"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95614.0" spread="45499.56"/>
                    <measurement group_id="O2" value="117172.0" spread="44501.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="267"/>
                    <count group_id="O2" value="266"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104873.0" spread="50346.69"/>
                    <measurement group_id="O2" value="137048.1" spread="53669.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Final staging</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="253"/>
                    <count group_id="O2" value="252"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86806.6" spread="43005.90"/>
                    <measurement group_id="O2" value="120995.7" spread="58731.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up, 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="164"/>
                    <count group_id="O2" value="183"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7802.9" spread="15672.57"/>
                    <measurement group_id="O2" value="8042.9" spread="12247.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up, 12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="139"/>
                    <count group_id="O2" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2380.1" spread="8494.06"/>
                    <measurement group_id="O2" value="1685.3" spread="6669.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of study/early treatment termination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="168"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9302.0" spread="27234.88"/>
                    <measurement group_id="O2" value="9553.9" spread="30723.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Randomization of first participant to clinical cutoff date (Up to 4 years)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Arm A</title>
          <description>Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
        </group>
        <group group_id="E2">
          <title>Arm B</title>
          <description>Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>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="126" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="116" subjects_at_risk="369"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA 15.0">Febrile Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes insipidus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA 15.0">Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Intestinal perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Abdominal wall haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Anal fistula</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Gastrointestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Ileal perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Ileus paralytic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Intra-abdominal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Small intestinal perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Subileus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Injection site warmth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Adverse drug reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis Acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Cholestasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Cytokine release syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Lung Infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Herpes Zoster</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Septic Shock</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Neutropenic sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Pneumocystis Jirovecii Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Pneumonia viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Soft tissue infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Bronchopulmonary Aspergillosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Gastroenteritis Bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Injection site abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Kidney infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Lymph node abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Mucosal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Oral fungal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 15.0">Oropharyngeal candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Peritonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Post procedural infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Progressive multifocal leukoencephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Pyoderma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Staphylococcal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 15.0">Tooth infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Genital infection bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Systemic infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Varicella zoster virus infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </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="2" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Body temperature increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </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="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 15.0">Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Hypernataemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Tumor lysis syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </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="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Gouty arthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Myofascial pain syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Myopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Papillary thyroid cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Renal cell cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Depressed level of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 15.0">Haemorrhage intracranial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Hypertensive encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Paraparesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Vith nerve paralysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephropathy toxic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Urinary tract pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="369"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA 15.0">Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 15.0">Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 15.0">Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Acute respiratory distress syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Purpura</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Stevens-Johnson syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Circulatory collapse</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 15.0">Orthostatic hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Vasculitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Venous thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Venous thrombosis limb</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="369"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="318" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="317" subjects_at_risk="369"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="51" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="70" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="79" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="68" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="369"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA 15.0">Nausea</sub_title>
                <counts group_id="E1" subjects_affected="83" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="102" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="59" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="60" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="57" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="50" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="369"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="69" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="91" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="55" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="48" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="369"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="369"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="63" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="69" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="369"/>
              </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="34" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="369"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="47" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="36" subjects_at_risk="369"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="369"/>
              </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="45" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="38" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="369"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="60" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="56" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="369"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="371"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="369"/>
              </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/NCT01724021
org study id: MO28457
secondary id: 2012-003230-17
nct id: NCT01724021
lead sponsor: 
has dmc: No
This multi-center, open-label, randomized study will evaluate the participant preference with
      subcutaneous versus intravenous administration of MabThera/Rituxan (rituximab) in
      participants with CD20+ diffuse large B-cell lymphoma or CD20+ follicular non-Hodgkin's
      lymphoma. In Arm A, participants will receive MabThera/Rituxan 375 mg/m2 intravenously (IV)
      on Day 1 of Cycle 1 and MabThera/Rituxan 1400 mg subcutaneously (SC) on Day 1 of Cycles 2-4,
      followed by MabThera/Rituxan IV in Cycles 5-8. Participants in Arm B will receive
      MabThera/Rituxan IV in Cycles 1-4 and SC in Cycles 5-8. All participants will receive 6-8
      cycles of standard chemotherapy (according to local country practice) with 8 cycles of
      MabThera/Rituxan. Anticipated time on study treatment is up to 24 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6
time frame: Cycle 6 (Up to 24 weeks)
description: Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing cycle 6.
measure: Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8
time frame: Cycle 8 (Up to 32 weeks)
description: Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing Cycle 8.
measure: Number of Participants With Treatment Emergent Adverse Events (AEs)
time frame: Randomization of first participant to clinical cutoff date (Up to 4 years)
description: An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
measure: Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV])
time frame: Cycle 1-4, Cycle 5-8 for both SC and IV (Up to 32 weeks)
description: Administration time was defined as the time from start to end of the SC injection or from start to end of the IV infusion
measure: Cancer Therapy Satisfaction Questionnaire (CTSQ) Score
time frame: During Cycle 4, 8 of treatment (Up to 32 weeks)
description: CTSQ is a validated 16-item questionnaire that measures three domains related to participants' satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.
measure: Rituximab Administration Satisfaction Questionnaire (RASQ) Score
time frame: During Cycle 4, 8 of treatment (Up to 32 weeks)
description: The RASQ is a 20-item questionnaire that measures five domains related to the impact of treatment administration. These include physical impact, psychological impact, impact on activities of daily living (ADLs), convenience, and satisfaction. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.
measure: Complete Response (CR) Rate
time frame: 28 days (± 3 days) after Day 1 of the last dose of induction treatment
description: CR rate was assessed according to the International Working Group (IWG) Response Criteria (CHESON ET AL. 1999) and included CR and CR unconfirmed (CRu). CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by > 75 % but still >1.5 cm in size, and indeterminate bone marrow assessment. Tumor assessments were based on computed tomography (CT) scans with contrast of the neck, chest, and abdomen (if detectable by these techniques) or other diagnostic means, if applicable. Other methods (e.g., MRI) were acceptable for participants in whom contrast CT scans were contraindicated. Due to the limited availability of FDG-PET scanners, an FDG-PET scan was not mandated in the study.
measure: Event-free Survival (EFS)
time frame: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
description: EFS was defined as the time from randomization to first occurrence of progression or relapse according to IWG response criteria. IWG criteria is defined using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; partial response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses; stable disease (SD): participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for progressive disease (PD); PD: Lymph nodes considered abnormal if the long axis is more than 1.5 centimeter (cm) regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes less than or equal to (<=) 1.0 × <= 1.0 cm would not be considered as abnormal for PD.
measure: Disease-free Survival (DFS)
time frame: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
description: DFS was defined as the period from the data of the initial CR/CRu until the date of relapse or death from any cause, whichever occurred first.
measure: Progression-free Survival (PFS)
time frame: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
description: PFS was defined as the time from randomization to the first occurrence of progression or relapse, according to the IWG response criteria. IWG criteria is defined criteria using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; PR: At least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses; SD: participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for PD; PD: Lymph nodes considered abnormal if the long axis is more than 1.5 cm regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes <= 1.0 × <= 1.0 cm would not be considered as abnormal for PD.
measure: Overall Survival (OS)
time frame: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
description: OS was defined as the time from randomization to death from any cause.
measure: Percentage of Participants With Anti-Rituximab Antibodies Over Time
time frame: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)
measure: Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time
time frame: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)
measure: Summary of Observed Serum Rituximab Concentration
time frame: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)
arm group label: Arm A
arm group type: Experimental
description: Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
arm group label: Arm B
arm group type: Experimental
description: Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
intervention type: Drug
intervention name: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP)
description: Standard chemotherapy
arm group label: Arm A
arm group label: Arm B
intervention type: Drug
intervention name: Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)
description: Standard chemotherapy
arm group label: Arm A
arm group label: Arm B
intervention type: Drug
intervention name: Bendamustine
description: Standard chemotherapy
arm group label: Arm A
arm group label: Arm B
other name: Treanda
intervention type: Drug
intervention name: Rituximab
description: 1400 mg subcutaneously (SC), Day 1 Cycles 2-4
arm group label: Arm A
other name: Rituxan
other name: MabThera
intervention type: Drug
intervention name: Rituximab
description: 375 mg/m2 IV, Day 1 Cycles 1-4
arm group label: Arm B
other name: Rituxan
other name: MabThera
intervention type: Drug
intervention name: Rituximab
description: 375 mg/m2 intravenously (IV), Day 1 Cycles 1 and 4-8
arm group label: Arm A
other name: Rituxan
other name: MabThera
intervention type: Drug
intervention name: Rituximab
description: 1400 mg SC, Day 1 Cycles 5-8
arm group label: Arm B
other name: Rituxan
other name: MabThera
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
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country: Argentina
country: Australia
country: Austria
country: Brazil
country: Canada
country: Chile
country: Colombia
country: Croatia
country: Denmark
country: Dominican Republic
country: Egypt
country: El Salvador
country: Germany
country: Guatemala
country: Hong Kong
country: Hungary
country: Indonesia
country: Italy
country: Korea, Republic of
country: Malaysia
country: Netherlands
country: New Zealand
country: Panama
country: Peru
country: Philippines
country: Portugal
country: Romania
country: Sweden
country: Taiwan
country: Thailand
country: Turkey
country: Vietnam
country: Belgium
country: Switzerland
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin
mesh term: Lymphoma, B-Cell
mesh term: Lymphoma, Large B-Cell, Diffuse
mesh term: Lymphoma, Follicular
mesh term: Prednisone
mesh term: Prednisolone
mesh term: Methylprednisolone Acetate
mesh term: Methylprednisolone
mesh term: Methylprednisolone Hemisuccinate
mesh term: Prednisolone acetate
mesh term: Cyclophosphamide
mesh term: Bendamustine Hydrochloride
mesh term: Rituximab
mesh term: Vincristine
mesh term: Doxorubicin
mesh term: Liposomal doxorubicin
mesh term: Prednisolone hemisuccinate
mesh term: Prednisolone phosphate
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 