<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/NCT01718691</url>
  </required_header>
  <id_info>
    <org_study_id>2011002</org_study_id>
    <nct_id>NCT01718691</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of SyB L-0501 in Combination With Rituximab in Patients With Untreated, Low-grade B Cell Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma</brief_title>
  <official_title>Phase II Clinical Study of SyB L-0501 in Combination With Rituximab in Patients With Untreated, Low-grade B-cell Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma (Multicenter, Open-label).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SymBio Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SymBio Pharmaceuticals</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the efficacy and safety of SyB L-0501 (two-day&#xD;
      consecutive 90 mg/m2/day IV drip infusions) in combination with rituximab (375 mg/m2 IV drip&#xD;
      infusion) on untreated, low-grade B cell non-Hodgkin's lymphoma and mantle cell lymphoma&#xD;
      where hematopoietic stem cell transplantation is not indicated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete Response Rate (CR + CRu) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC)</measure>
    <time_frame>Up to 30 weeks</time_frame>
    <description>The criteria for CR and CRu based on IWRC are shown below.&#xD;
CR: Fulfills all of the following&#xD;
Disappearance of all detectable disease&#xD;
LN* &gt; 1.5 cm must decrease to ≤ 1.5 cm&#xD;
CRu: Fulfills all of the following&#xD;
LN &gt;1.5 cm; SPD** decrease &gt;75%&#xD;
indeterminate bone marrow&#xD;
LN: lymph nodes or nodal masses ** SPD: sum of the products of the greatest diameters</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (Antitumor Effect: PR or Better) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC)</measure>
    <time_frame>Up to 30 weeks</time_frame>
    <description>The criteria for PR based on IWRC are shown below.&#xD;
PR: SPD regressed &gt; 50%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Response Rate (CR) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC)</measure>
    <time_frame>Up to 30 weeks</time_frame>
    <description>The criteria for CR based on the Revised RC are shown below.&#xD;
Definition: Disappearance of all evidence of disease&#xD;
Nodal Masses:&#xD;
[18F]fluorodeoxyglucose (FDG)-avid or PET positive prior to therapy; mass of any size permitted if PET negative.&#xD;
Variably FDG-avid or PET negative; regression to normal size on CT.&#xD;
Spleen, Liver:&#xD;
Not palpable, nodules disappeared&#xD;
Bone Marrow:&#xD;
Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (PR or Better) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC)</measure>
    <time_frame>Up to 30 weeks</time_frame>
    <description>The criteria for PR based on the Revised RC are shown below.&#xD;
Definition: Regression of measurable disease and no new sites&#xD;
Nodal Masses:&#xD;
50% or more decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes&#xD;
FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site&#xD;
Variably FDG-avid or PET negative; regression on CT&#xD;
Spleen, Liver:&#xD;
50% or more decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen&#xD;
Bone Marrow:&#xD;
Irrelevant if positive prior to therapy; cell type should be specified.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Response Rate Based on WHO Handbook for Reporting Results of Cancer Treatment (1979)</measure>
    <time_frame>Up to 30 weeks</time_frame>
    <description>The criteria for Complete response based on WHO Handbook for Reporting Results of Cancer Treatment (1979) are shown below.&#xD;
Measurable disease:&#xD;
The disappearance of all known disease, determined by 2 observations not less than 4 weeks apart.&#xD;
Unmeasurable disease:&#xD;
Complete disappearance of all known disease for at least 4 weeks.&#xD;
Bone metastases:&#xD;
Complete disappearance of all lesions on X-ray or scan for at least 4 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (PR or Better) Based on &quot;WHO Handbook for Reporting Results of Cancer Treatment (1979)&quot;</measure>
    <time_frame>Up to 30 weeks</time_frame>
    <description>The criteria for Overall response rate (PR or better) based on &quot;WHO Handbook for Reporting Results of Cancer Treatment (1979)&quot; are shown below.&#xD;
Definition of PR:&#xD;
Measurable disease:&#xD;
50% or more decrease in total tumor size of the lesions which have been measured to determine the effect of therapy by 2 observations not less than 4 weeks apart. In addition there can be no appearance of new lesions or progression of any lesion.&#xD;
Unmeasurable disease:&#xD;
Estimated decrease in tumor size of 50% or more for at least 4 weeks.&#xD;
Bone metastases:&#xD;
Partial decrease in size of lytic lesions, recalcification of lytic lesions, or decreased density of blastic lesions for at least 4 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>Up to 30 weeks</time_frame>
    <description>PFS is the period from registration date to the earliest onset date of any progression event calculated using the Kaplan-Meier estimator. The median and the 95% confidence interval (CI) were calculated using Greenwood's formula.&#xD;
Progression event was defined as progression (includes recurrence/relapse), initiation of post-study treatment, confirmation of other malignant tumor, or death due to any given cause. The date of progression was determined based on overall response assessed using IWRC, Revised RC, and WHO, and assessment by the primary physicians (excluding overall response).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>Up to 30 weeks</time_frame>
    <description>DOR is the period from the date of achieving CR, CRu or PR in the responders to the earliest onset date of any progression events calculated using the Kaplan-Meier estimator. The median and the 95% CI were calculated using Greenwood's formula.&#xD;
The date of achieving CR, CRu or PR was determined based on the overall response assessed using IWRC. The date of progression was determined based on overall response assessed using IWRC, Revised RC and WHO, and assessment by the primary physicians (excluding overall response).&#xD;
Progression event was defined as progression (includes recurrence/relapse), initiation of post-study treatment, confirmation of other malignant tumor, or death due to any given cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to 30 weeks</time_frame>
    <description>Death due to any given cause was defined as an event. OS was calculated using the Kaplan-Meier estimator. The median and the 95% CI were calculated using Greenwood's formula.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Discontinuation Due to Adverse Event</measure>
    <time_frame>up to 30 weeks</time_frame>
    <description>Adverse events were evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.0, Japan Clinical Oncology Group/Japan Society of Clinical Oncology (JCOG/JSCO) version, and were encoded using Medical Dictionary for Regulatory Activities (MedDRA) Ver.16.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory Test Abnormalities (Biochemical Tests)</measure>
    <time_frame>up to 30 weeks</time_frame>
    <description>Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE. Grade 1 : mild Grade 2 : moderate Grade 3 : severe or medically significant but not immediately life-threatening Grade 4 : life threatening or disabling Grade 5 : death related to AE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory Test Abnormalities (Hematology Tests)</measure>
    <time_frame>up to 30 weeks</time_frame>
    <description>Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE. Grade 1 : mild Grade 2 : moderate Grade 3 : severe or medically significant but not immediately life-threatening Grade 4 : life threatening or disabling Grade 5 : death related to AE</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Low-grade B Cell Non-Hodgkin's Lymphoma</condition>
  <condition>Mantle Cell Lymphoma Where Hematopoietic Stem Cell Transplantation is Not Indicated</condition>
  <arm_group>
    <arm_group_label>SyB L-0501＋rituximab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SyB L-0501</intervention_name>
    <description>A dose of 90 mg/m^2/day of SyB L-0501 is administered on Day 1 and Day 2 as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times.</description>
    <arm_group_label>SyB L-0501＋rituximab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>rituximab</intervention_name>
    <description>A dose of 375 mg/m^2 of rituximab is administered on Day 1 (Day 0 in Cycle 1 only) as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times. From Cycle 2, rituximab will be coadministered with SyB L-0501 on Day 1. However, if the investigator or sub-investigator judges that the coadministration is difficult, rituximab may be administered on Day 0.</description>
    <arm_group_label>SyB L-0501＋rituximab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who are histopathologically confirmed to have the following cluster of&#xD;
             differentiation 20 (CD20) positive low-grade B cell non-Hodgkin's lymphoma or mantle&#xD;
             cell lymphoma by lymph node biopsy or evaluable tissue biopsy within 6 months before&#xD;
             the registration WHO Classification of Tumors (fourth edition):&#xD;
&#xD;
               -  Small lymphocytic lymphoma&#xD;
&#xD;
               -  Splenic marginal zone B-cell lymphoma&#xD;
&#xD;
               -  Lymphoplasmacytic lymphoma&#xD;
&#xD;
               -  Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue&#xD;
                  (MALT lymphoma)&#xD;
&#xD;
               -  Nodal marginal zone B-cell lymphoma&#xD;
&#xD;
               -  Follicular lymphoma (Grade 1, 2, 3a)&#xD;
&#xD;
               -  Mantle cell lymphoma&#xD;
&#xD;
          2. Patients with a measurable lesion ( &gt; 1.5 cm in major axis on CT)&#xD;
&#xD;
          3. Patients without a medical history&#xD;
&#xD;
          4. Patients with at least 1 of the following clinical symptoms or signs (excluding mantle&#xD;
             cell lymphoma):&#xD;
&#xD;
               -  Bulky disease measuring &gt; 7 cm in major axis on CT (excluding spleen)&#xD;
&#xD;
               -  B symptoms&#xD;
&#xD;
                    1. Fever exceeding 38.0ºC of unknown cause&#xD;
&#xD;
                    2. Night sweats&#xD;
&#xD;
                    3. Weight decrease exceeding 10% within 6 months before patient registration&#xD;
&#xD;
               -  Elevated serum LDH or beta 2 microglobulin&#xD;
&#xD;
               -  Three or more regional lymph nodes of &gt; 3 cm in major axis on CT&#xD;
&#xD;
               -  Symptomatic splenomegaly&#xD;
&#xD;
               -  Intracranial pressure&#xD;
&#xD;
               -  Pleural effusion/ascites retention&#xD;
&#xD;
          5. Patients expected to live for at least 3 months&#xD;
&#xD;
          6. Patients aged between 20 and 79 years (at the time of registration)&#xD;
&#xD;
          7. Patients whose Eastern Cooperative Oncology Group (ECOG) performance status (P.S.) is&#xD;
             0～2&#xD;
&#xD;
          8. Patients with adequately maintained major organ function (bone marrow, heart, lungs,&#xD;
             liver, kidneys)&#xD;
&#xD;
               -  Neutrophil count: not less than 1,500 /mm3&#xD;
&#xD;
               -  Platelet count: not less than 75,000 /mm3&#xD;
&#xD;
               -  Aspartate aminotransferase (AST)[Glutamic oxaloacetic transaminase (GOT)]: not&#xD;
                  more than 3 times the standard upper limit for the site&#xD;
&#xD;
               -  Alanine aminotransferase (ALT)[Glutamic pyruvic transaminase (GPT)]: not more&#xD;
                  than 3 times the standard upper limit for the site&#xD;
&#xD;
               -  Total bilirubin: not more than 1.5 times the standard upper limit for the site&#xD;
&#xD;
               -  Serum creatinine: not more than 1.5 times the standard upper limit for the site&#xD;
&#xD;
               -  Arterial partial pressure of oxygen (PaO2): not less than 65 mmHg&#xD;
&#xD;
               -  Electrocardiogram shows no abnormal findings that require treatment&#xD;
&#xD;
               -  Echocardiogram of left ventricular ejection fraction (LVEF): not less than 55%&#xD;
&#xD;
          9. Patients whose informed consent has been obtained in person&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients who fall under any one of the following criteria are to be excluded&#xD;
&#xD;
          1. Patients whose transformation has been confirmed histopathologically&#xD;
&#xD;
          2. Mantle cell lymphoma patients aged 65 years or younger&#xD;
&#xD;
          3. Patients who were administered or received transfusion of cytokine formulations such&#xD;
             as G-CSF (granulocyte colony stimulating factor) and erythropoietin within 14 days&#xD;
             before pre-registration test&#xD;
&#xD;
          4. Patients with severe active infectious disorders (receiving antibiotics, antifungals,&#xD;
             or antivirus IV injection)&#xD;
&#xD;
          5. Patients with serious complications (such as hepatic or renal failure)&#xD;
&#xD;
          6. Patients with severe complications of cardiac disease (examples: myocardial&#xD;
             infarction, ischemic heart disease) or its previous history within 2 years before&#xD;
             patient registration, and patients with arrhythmia requiring a treatment&#xD;
&#xD;
          7. Patients with serious gastrointestinal conditions (persistent or severe&#xD;
             nausea/vomiting or diarrhea)&#xD;
&#xD;
          8. Patients who are positive for hepatitis B surface (HBs) antigen, hepatitis C virus&#xD;
             (HCV) antibody or HIV antibody [if HBs or hepatitis B core (HBc) positive, patients&#xD;
             whose hepatitis B virus (HBV)-DNA test results indicate positive]&#xD;
&#xD;
          9. Patients with serious bleeding tendencies [such as disseminated intravascular&#xD;
             coagulation (DIC)]&#xD;
&#xD;
         10. Patients having or suspected of having symptoms indicative of the central nervous&#xD;
             system (CNS) involvement&#xD;
&#xD;
         11. Patients with interstitial pneumonitis, pulmonary fibrosis, pulmonary emphysema&#xD;
             complications requiring treatment or its medical history.&#xD;
&#xD;
         12. Patients with active multiple primary cancer&#xD;
&#xD;
         13. Patients who received chemotherapy, radiotherapy, antibody therapy and antitumor&#xD;
             steroid therapy in the past&#xD;
&#xD;
         14. Patients with complications or medical history of autoimmune haemolytic anaemia&#xD;
&#xD;
         15. Patients who were administered investigative or unapproved drugs within 3 months&#xD;
             before patient registration&#xD;
&#xD;
         16. Patients with addiction to drugs or narcotics, or alcoholism&#xD;
&#xD;
         17. Patients who have previously received hematopoietic stem cell transplantation&#xD;
&#xD;
         18. Patients who are or may be pregnant, lactating patients&#xD;
&#xD;
         19. Patients, whether male or female, who do not agree to use contraception&#xD;
&#xD;
         20. Patients otherwise judged by the investigator or the sub-investigator to be unsuitable&#xD;
             for inclusion in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Kashiwa</city>
        <state>Chiba</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Isehara</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Sendai</city>
        <state>Miyagi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Moriguchi</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Izumo</city>
        <state>Shimane</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Hamamatsu</city>
        <state>Shizuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Utsunomiya</city>
        <state>Tochigi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Kagoshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Kyoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Nagasaki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <results_first_submitted>June 19, 2015</results_first_submitted>
  <results_first_submitted_qc>March 24, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 27, 2016</results_first_posted>
  <last_update_submitted>March 24, 2016</last_update_submitted>
  <last_update_submitted_qc>March 24, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 27, 2016</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, Mantle-Cell</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rituximab</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Low-grade B-cell Non-Hodgkin's Lymphoma</title>
          <description>Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma.</description>
        </group>
        <group group_id="P2">
          <title>Mantle Cell Lymphoma</title>
          <description>Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Of the 70 subjects enrolled, one who did not receive the investigational product was excluded. Therefore, the total number of Baseline Participants is 69.</population>
      <group_list>
        <group group_id="B1">
          <title>Low-grade B-cell Non-Hodgkin's Lymphoma</title>
          <description>Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma</description>
        </group>
        <group group_id="B2">
          <title>Mantle Cell Lymphoma</title>
          <description>Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma</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="59"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="69"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>˂65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="33"/>
                  </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="37"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Performance status (ECOG scale)</title>
          <description>The criteria of Eastern Cooperative Oncology Group (ECOG) performance status are shown below.&#xD;
0: Symptoms are absent, no restrictions on lifestyle&#xD;
Symptoms are present; no restrictions on walking; Strenuous physical activity is restricted&#xD;
Symptoms are present; able to walk; able to perform self-care; Spends over 50% of waking hours out of bed</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diagnosis (WHO classification)</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Small lymphocytic lymphoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphoplasmacytic lymphoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Splenic marginal zone lymphoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B-EMZL(MALT lymphoma)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nodal marginal zone B-cell lymphoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follicular lymphoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mantle cell lymphoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Clinical stage (Ann Arbor staging classification)</title>
          <description>The criteria of Ann Arbor staging classification are shown below.&#xD;
I: Invasion of 1 lymph node region II: Invasion of 2 or more lymphatic regions confined to 1 side of the diaphragm III: Invasion of multiple lymph node regions spanning above and below the diaphragm IV: Diffuse invasion to an organ or area other than 1 or multiple lymphatic tissues, regardless of the presence/absence of lymph node lesions.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>I - II</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>III</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of lymph node regions</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>0 region</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 region</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 regions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 regions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 regions or more</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of extranodal lesions</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>0 - 1 lesion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 or more lesions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tumor diameter (1)</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>≥5 cm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>˂5 cm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tumor diameter (2)</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>≥7 cm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>˂7 cm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Lactate dehydrogenase (LDH)</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>≤ upper limit of normal range</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Beta 2 microglobulin</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>≤ upper limit of normal range</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>C-reactive protein (CRP)</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>≤ upper limit of normal range</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hepatomegaly</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Splenomegaly</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Enlarged kidney</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>B symptoms (fever)</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>B symptoms (night sweats)</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>B symptoms (weight loss)</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Symptomatic splenomegaly</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pressure symptoms</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pleural effusion/ascites retention</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Bone marrow invasion</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Undetermined</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Chromosome abnormality</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Previous medical history</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Concomitant disease</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>FLIPI risk category</title>
          <description>The criteria for Follicular Lymphoma International Prognostic Index (FLIPI) are shown below.&#xD;
Low: No or 1 poor prognostic factor(s)&#xD;
Intermediate: 2 poor prognostic factors&#xD;
High: 3-5 poor prognostic factors</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="NA">The subjects with mantle cell lymphoma were not included in this examination.</measurement>
                    <measurement group_id="B3" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intermediate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="NA">The subjects with mantle cell lymphoma were not included in this examination.</measurement>
                    <measurement group_id="B3" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="NA">The subjects with mantle cell lymphoma were not included in this examination.</measurement>
                    <measurement group_id="B3" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>IPI risk category</title>
          <description>The criteria for International Prognostic Index are shown below.&#xD;
Low: 0 or 1poor prognostic factors&#xD;
Intermediate (Low): 2 poor prognostic factors&#xD;
Intermediate (High): 3 poor prognostic factors&#xD;
High: 4 or 5 poor prognostic factors</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intermediate (Low)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intermediate (High)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Complete Response Rate (CR + CRu) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC)</title>
        <description>The criteria for CR and CRu based on IWRC are shown below.&#xD;
CR: Fulfills all of the following&#xD;
Disappearance of all detectable disease&#xD;
LN* &gt; 1.5 cm must decrease to ≤ 1.5 cm&#xD;
CRu: Fulfills all of the following&#xD;
LN &gt;1.5 cm; SPD** decrease &gt;75%&#xD;
indeterminate bone marrow&#xD;
LN: lymph nodes or nodal masses ** SPD: sum of the products of the greatest diameters</description>
        <time_frame>Up to 30 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low-grade B-cell Non-Hodgkin's Lymphoma</title>
            <description>Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma</description>
          </group>
          <group group_id="O2">
            <title>Mantle Cell Lymphoma</title>
            <description>Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma</description>
          </group>
          <group group_id="O3">
            <title>Total</title>
            <description>All subjects in the SyB L-0501＋ rituximab arm</description>
          </group>
        </group_list>
        <measure>
          <title>Complete Response Rate (CR + CRu) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC)</title>
          <description>The criteria for CR and CRu based on IWRC are shown below.&#xD;
CR: Fulfills all of the following&#xD;
Disappearance of all detectable disease&#xD;
LN* &gt; 1.5 cm must decrease to ≤ 1.5 cm&#xD;
CRu: Fulfills all of the following&#xD;
LN &gt;1.5 cm; SPD** decrease &gt;75%&#xD;
indeterminate bone marrow&#xD;
LN: lymph nodes or nodal masses ** SPD: sum of the products of the greatest diameters</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.8"/>
                    <measurement group_id="O2" value="70.0"/>
                    <measurement group_id="O3" value="68.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Response Rate (Antitumor Effect: PR or Better) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC)</title>
        <description>The criteria for PR based on IWRC are shown below.&#xD;
PR: SPD regressed &gt; 50%</description>
        <time_frame>Up to 30 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low-grade B-cell Non-Hodgkin's Lymphoma</title>
            <description>Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma</description>
          </group>
          <group group_id="O2">
            <title>Mantle Cell Lymphoma</title>
            <description>Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma</description>
          </group>
          <group group_id="O3">
            <title>Total</title>
            <description>All subjects in the SyB L-0501＋ rituximab arm</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Response Rate (Antitumor Effect: PR or Better) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC)</title>
          <description>The criteria for PR based on IWRC are shown below.&#xD;
PR: SPD regressed &gt; 50%</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.6"/>
                    <measurement group_id="O2" value="90.0"/>
                    <measurement group_id="O3" value="95.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Complete Response Rate (CR) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC)</title>
        <description>The criteria for CR based on the Revised RC are shown below.&#xD;
Definition: Disappearance of all evidence of disease&#xD;
Nodal Masses:&#xD;
[18F]fluorodeoxyglucose (FDG)-avid or PET positive prior to therapy; mass of any size permitted if PET negative.&#xD;
Variably FDG-avid or PET negative; regression to normal size on CT.&#xD;
Spleen, Liver:&#xD;
Not palpable, nodules disappeared&#xD;
Bone Marrow:&#xD;
Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative.</description>
        <time_frame>Up to 30 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low-grade B-cell Non-Hodgkin's Lymphoma</title>
            <description>Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma.</description>
          </group>
          <group group_id="O2">
            <title>Mantle Cell Lymphoma</title>
            <description>Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma.</description>
          </group>
          <group group_id="O3">
            <title>Total</title>
            <description>All subjects in the SyB L-0501＋ rituximab arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Complete Response Rate (CR) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC)</title>
          <description>The criteria for CR based on the Revised RC are shown below.&#xD;
Definition: Disappearance of all evidence of disease&#xD;
Nodal Masses:&#xD;
[18F]fluorodeoxyglucose (FDG)-avid or PET positive prior to therapy; mass of any size permitted if PET negative.&#xD;
Variably FDG-avid or PET negative; regression to normal size on CT.&#xD;
Spleen, Liver:&#xD;
Not palpable, nodules disappeared&#xD;
Bone Marrow:&#xD;
Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.4"/>
                    <measurement group_id="O2" value="80.0"/>
                    <measurement group_id="O3" value="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Response Rate (PR or Better) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC)</title>
        <description>The criteria for PR based on the Revised RC are shown below.&#xD;
Definition: Regression of measurable disease and no new sites&#xD;
Nodal Masses:&#xD;
50% or more decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes&#xD;
FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site&#xD;
Variably FDG-avid or PET negative; regression on CT&#xD;
Spleen, Liver:&#xD;
50% or more decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen&#xD;
Bone Marrow:&#xD;
Irrelevant if positive prior to therapy; cell type should be specified.</description>
        <time_frame>Up to 30 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low-grade B-cell Non-Hodgkin's Lymphoma</title>
            <description>Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma</description>
          </group>
          <group group_id="O2">
            <title>Mantle Cell Lymphoma</title>
            <description>Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma</description>
          </group>
          <group group_id="O3">
            <title>Total</title>
            <description>All subjects in the SyB L-0501＋ rituximab arm</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Response Rate (PR or Better) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC)</title>
          <description>The criteria for PR based on the Revised RC are shown below.&#xD;
Definition: Regression of measurable disease and no new sites&#xD;
Nodal Masses:&#xD;
50% or more decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes&#xD;
FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site&#xD;
Variably FDG-avid or PET negative; regression on CT&#xD;
Spleen, Liver:&#xD;
50% or more decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen&#xD;
Bone Marrow:&#xD;
Irrelevant if positive prior to therapy; cell type should be specified.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.6"/>
                    <measurement group_id="O2" value="90.0"/>
                    <measurement group_id="O3" value="95.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Complete Response Rate Based on WHO Handbook for Reporting Results of Cancer Treatment (1979)</title>
        <description>The criteria for Complete response based on WHO Handbook for Reporting Results of Cancer Treatment (1979) are shown below.&#xD;
Measurable disease:&#xD;
The disappearance of all known disease, determined by 2 observations not less than 4 weeks apart.&#xD;
Unmeasurable disease:&#xD;
Complete disappearance of all known disease for at least 4 weeks.&#xD;
Bone metastases:&#xD;
Complete disappearance of all lesions on X-ray or scan for at least 4 weeks.</description>
        <time_frame>Up to 30 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low-grade B-cell Non-Hodgkin's Lymphoma</title>
            <description>Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma</description>
          </group>
          <group group_id="O2">
            <title>Mantle Cell Lymphoma</title>
            <description>Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma</description>
          </group>
          <group group_id="O3">
            <title>Total</title>
            <description>All subjects in the SyB L-0501＋ rituximab arm</description>
          </group>
        </group_list>
        <measure>
          <title>Complete Response Rate Based on WHO Handbook for Reporting Results of Cancer Treatment (1979)</title>
          <description>The criteria for Complete response based on WHO Handbook for Reporting Results of Cancer Treatment (1979) are shown below.&#xD;
Measurable disease:&#xD;
The disappearance of all known disease, determined by 2 observations not less than 4 weeks apart.&#xD;
Unmeasurable disease:&#xD;
Complete disappearance of all known disease for at least 4 weeks.&#xD;
Bone metastases:&#xD;
Complete disappearance of all lesions on X-ray or scan for at least 4 weeks.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.0"/>
                    <measurement group_id="O2" value="40.0"/>
                    <measurement group_id="O3" value="24.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Response Rate (PR or Better) Based on &quot;WHO Handbook for Reporting Results of Cancer Treatment (1979)&quot;</title>
        <description>The criteria for Overall response rate (PR or better) based on &quot;WHO Handbook for Reporting Results of Cancer Treatment (1979)&quot; are shown below.&#xD;
Definition of PR:&#xD;
Measurable disease:&#xD;
50% or more decrease in total tumor size of the lesions which have been measured to determine the effect of therapy by 2 observations not less than 4 weeks apart. In addition there can be no appearance of new lesions or progression of any lesion.&#xD;
Unmeasurable disease:&#xD;
Estimated decrease in tumor size of 50% or more for at least 4 weeks.&#xD;
Bone metastases:&#xD;
Partial decrease in size of lytic lesions, recalcification of lytic lesions, or decreased density of blastic lesions for at least 4 weeks.</description>
        <time_frame>Up to 30 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low-grade B-cell Non-Hodgkin's Lymphoma</title>
            <description>Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma</description>
          </group>
          <group group_id="O2">
            <title>Mantle Cell Lymphoma</title>
            <description>Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma</description>
          </group>
          <group group_id="O3">
            <title>Total</title>
            <description>All subjects in the SyB L-0501＋ rituximab arm</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Response Rate (PR or Better) Based on &quot;WHO Handbook for Reporting Results of Cancer Treatment (1979)&quot;</title>
          <description>The criteria for Overall response rate (PR or better) based on &quot;WHO Handbook for Reporting Results of Cancer Treatment (1979)&quot; are shown below.&#xD;
Definition of PR:&#xD;
Measurable disease:&#xD;
50% or more decrease in total tumor size of the lesions which have been measured to determine the effect of therapy by 2 observations not less than 4 weeks apart. In addition there can be no appearance of new lesions or progression of any lesion.&#xD;
Unmeasurable disease:&#xD;
Estimated decrease in tumor size of 50% or more for at least 4 weeks.&#xD;
Bone metastases:&#xD;
Partial decrease in size of lytic lesions, recalcification of lytic lesions, or decreased density of blastic lesions for at least 4 weeks.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.4"/>
                    <measurement group_id="O2" value="90.0"/>
                    <measurement group_id="O3" value="87.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-Free Survival (PFS)</title>
        <description>PFS is the period from registration date to the earliest onset date of any progression event calculated using the Kaplan-Meier estimator. The median and the 95% confidence interval (CI) were calculated using Greenwood's formula.&#xD;
Progression event was defined as progression (includes recurrence/relapse), initiation of post-study treatment, confirmation of other malignant tumor, or death due to any given cause. The date of progression was determined based on overall response assessed using IWRC, Revised RC, and WHO, and assessment by the primary physicians (excluding overall response).</description>
        <time_frame>Up to 30 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low-grade B-cell Non-Hodgkin's Lymphoma</title>
            <description>Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma</description>
          </group>
          <group group_id="O2">
            <title>Mantle Cell Lymphoma</title>
            <description>Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma</description>
          </group>
          <group group_id="O3">
            <title>Total</title>
            <description>All subjects in the SyB L-0501＋ rituximab arm</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-Free Survival (PFS)</title>
          <description>PFS is the period from registration date to the earliest onset date of any progression event calculated using the Kaplan-Meier estimator. The median and the 95% confidence interval (CI) were calculated using Greenwood's formula.&#xD;
Progression event was defined as progression (includes recurrence/relapse), initiation of post-study treatment, confirmation of other malignant tumor, or death due to any given cause. The date of progression was determined based on overall response assessed using IWRC, Revised RC, and WHO, and assessment by the primary physicians (excluding overall response).</description>
          <units>days</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="59"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="654.0" upper_limit="NA">The PFS rate during this observation period was 57.7%, which was higher than 50% and therefore, 50% PFS could not be calculated.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">The PFS rate during this observation period was 57.7%, which was higher than 50% and therefore, 50% PFS could not be calculated.</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="654.0" upper_limit="NA">The PFS rate during this observation period was 57.7%, which was higher than 50% and therefore, 50% PFS could not be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DOR)</title>
        <description>DOR is the period from the date of achieving CR, CRu or PR in the responders to the earliest onset date of any progression events calculated using the Kaplan-Meier estimator. The median and the 95% CI were calculated using Greenwood's formula.&#xD;
The date of achieving CR, CRu or PR was determined based on the overall response assessed using IWRC. The date of progression was determined based on overall response assessed using IWRC, Revised RC and WHO, and assessment by the primary physicians (excluding overall response).&#xD;
Progression event was defined as progression (includes recurrence/relapse), initiation of post-study treatment, confirmation of other malignant tumor, or death due to any given cause.</description>
        <time_frame>Up to 30 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low-grade B-cell Non-Hodgkin's Lymphoma</title>
            <description>Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma</description>
          </group>
          <group group_id="O2">
            <title>Mantle Cell Lymphoma</title>
            <description>Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma</description>
          </group>
          <group group_id="O3">
            <title>Total</title>
            <description>All subjects in the SyB L-0501＋ rituximab arm</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response (DOR)</title>
          <description>DOR is the period from the date of achieving CR, CRu or PR in the responders to the earliest onset date of any progression events calculated using the Kaplan-Meier estimator. The median and the 95% CI were calculated using Greenwood's formula.&#xD;
The date of achieving CR, CRu or PR was determined based on the overall response assessed using IWRC. The date of progression was determined based on overall response assessed using IWRC, Revised RC and WHO, and assessment by the primary physicians (excluding overall response).&#xD;
Progression event was defined as progression (includes recurrence/relapse), initiation of post-study treatment, confirmation of other malignant tumor, or death due to any given cause.</description>
          <units>days</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="59"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="541.0" upper_limit="NA">Because response was maintained in most subjects (of 66 subjects assessed as PR or better in the overall response assessment, eleven experienced a progression event).</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Because response was maintained in most subjects (of 66 subjects assessed as PR or better in the overall response assessment, eleven experienced a progression event).</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="541.0" upper_limit="NA">Because response was maintained in most subjects (of 66 subjects assessed as PR or better in the overall response assessment, eleven experienced a progression event).</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>Death due to any given cause was defined as an event. OS was calculated using the Kaplan-Meier estimator. The median and the 95% CI were calculated using Greenwood's formula.</description>
        <time_frame>Up to 30 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low-grade B-cell Non-Hodgkin's Lymphoma</title>
            <description>Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma</description>
          </group>
          <group group_id="O2">
            <title>Mantle Cell Lymphoma</title>
            <description>Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma</description>
          </group>
          <group group_id="O3">
            <title>Total</title>
            <description>All subjects in the SyB L-0501＋ rituximab arm</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>Death due to any given cause was defined as an event. OS was calculated using the Kaplan-Meier estimator. The median and the 95% CI were calculated using Greenwood's formula.</description>
          <units>days</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="59"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="69"/>
              </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">Because no event of death occurred.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Because no event of death occurred.</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">Because no event of death occurred.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Discontinuation Due to Adverse Event</title>
        <description>Adverse events were evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.0, Japan Clinical Oncology Group/Japan Society of Clinical Oncology (JCOG/JSCO) version, and were encoded using Medical Dictionary for Regulatory Activities (MedDRA) Ver.16.1.</description>
        <time_frame>up to 30 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Total</title>
            <description>All subjects in the SyB L-0501＋ rituximab arm</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Discontinuation Due to Adverse Event</title>
          <description>Adverse events were evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.0, Japan Clinical Oncology Group/Japan Society of Clinical Oncology (JCOG/JSCO) version, and were encoded using Medical Dictionary for Regulatory Activities (MedDRA) Ver.16.1.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adverse drug reaction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discontinuation due to adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Laboratory Test Abnormalities (Biochemical Tests)</title>
        <description>Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE. Grade 1 : mild Grade 2 : moderate Grade 3 : severe or medically significant but not immediately life-threatening Grade 4 : life threatening or disabling Grade 5 : death related to AE</description>
        <time_frame>up to 30 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Total</title>
            <description>All subjects in the SyB L-0501＋ rituximab arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Laboratory Test Abnormalities (Biochemical Tests)</title>
          <description>Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE. Grade 1 : mild Grade 2 : moderate Grade 3 : severe or medically significant but not immediately life-threatening Grade 4 : life threatening or disabling Grade 5 : death related to AE</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 3 : AST(GOT)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 : ALT(GPT)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 : γ-GTP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 : Uric acid</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 : Na decrease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 : K decrease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 : K increase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Laboratory Test Abnormalities (Hematology Tests)</title>
        <description>Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE. Grade 1 : mild Grade 2 : moderate Grade 3 : severe or medically significant but not immediately life-threatening Grade 4 : life threatening or disabling Grade 5 : death related to AE</description>
        <time_frame>up to 30 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Total</title>
            <description>All subjects in the SyB L-0501＋ rituximab arm</description>
          </group>
        </group_list>
        <measure>
          <title>Laboratory Test Abnormalities (Hematology Tests)</title>
          <description>Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE. Grade 1 : mild Grade 2 : moderate Grade 3 : severe or medically significant but not immediately life-threatening Grade 4 : life threatening or disabling Grade 5 : death related to AE</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 3 : White blood cell count decreased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 : White blood cell count decreased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 : Neutrophil count decreased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 : Neutrophil count decreased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 : Lymphocyte count decreased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 : Lymphocyte count decreased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 : Haemoglobin decreased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 : Platelet count decreased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 : Platelet count decreased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>SyB L-0501＋Rituximab</title>
          <description>Drug: SyB L-0501&#xD;
A dose of 90 mg/m^2/day of SyB L-0501 is administered on Day 1 and Day 2 as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times.&#xD;
Drug: rituximab&#xD;
A dose of 375 mg/m^2 of rituximab is administered on Day 1 (Day 0 in Cycle 1 only) as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times. From Cycle 2, rituximab will be coadministered with SyB L-0501 on Day 1. However, if the investigator or sub-investigator judges that the coadministration is difficult, rituximab may be administered on Day 0.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 16.1</default_vocab>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>atrial tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>cytogenetic abnormality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>pneumonia cytomegaloviral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>tumour lysis syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>dermatitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 16.1</default_vocab>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="69" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Lymphadenitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Ventricular arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>External ear inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Steroid withdrawal syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenopia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Erythema of eyelid</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Scintillating scotoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Trichiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Anal fissure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Cheilitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Colitis ischaemic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="46" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Oesophageal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Proctalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Injection site induration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Injection site phlebitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Local swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Thirst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Infusion site extravasation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Injection site vasculitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Liver disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Gallbladder polyp</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Hypogammaglobulinaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Sarcoidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Chronic sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Hepatitis viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Herpes simplex</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus viraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Bacterial infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Acarodermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Aspergillus infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod sting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Beta 2 microglobulin increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Blood albumin decreased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Blood immunoglobulin A decreased</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Blood immunoglobulin G decreased</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Blood immunoglobulin M decreased</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Blood potassium decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Blood urea increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Blood uric acid increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>CD4 lymphocytes decreased</sub_title>
                <counts group_id="E1" subjects_affected="64" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Electrocardiogram QT prolonged</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Eosinophil count increased</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Blood urine present</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Low density lipoprotein increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="67" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Lymphocyte count increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Monocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="65" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Neutrophil count increased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Protein total decreased</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Protein urine</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Red blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="69" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>White blood cell count increased</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Blood bilirubin decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Neutrophil percentage decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Neutrophil percentage increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Electrocardiogram ST-T segment abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Occult blood</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </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="69"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Hypertriglyceridaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Tumour lysis syndrome</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Periarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Tenosynovitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Dizziness postural</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Sensory disturbance</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Lacunar infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Breast swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract inflammation</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Oropharyngeal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Dermatitis exfoliative</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Drug eruption</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Eczema asteatotic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Erythema multiforme</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Ingrowing nail</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Miliaria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Palmar-plantar erythrodysaesthesia syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Papule</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Xeroderma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Tooth extraction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Phlebitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Vascular pain</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Vasculitis</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="69"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Toshihiko Nagase</name_or_title>
      <organization>SymBio Pharmaceuticals</organization>
      <phone>+81-3-5472-1125</phone>
    </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/NCT01718691
org study id: 2011002
nct id: NCT01718691
lead sponsor: 
The purpose of this study is to assess the efficacy and safety of SyB L-0501 (two-day
      consecutive 90 mg/m2/day IV drip infusions) in combination with rituximab (375 mg/m2 IV drip
      infusion) on untreated, low-grade B cell non-Hodgkin's lymphoma and mantle cell lymphoma
      where hematopoietic stem cell transplantation is not indicated.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Complete Response Rate (CR + CRu) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC)
time frame: Up to 30 weeks
description: The criteria for CR and CRu based on IWRC are shown below.
CR: Fulfills all of the following
Disappearance of all detectable disease
LN* > 1.5 cm must decrease to ≤ 1.5 cm
CRu: Fulfills all of the following
LN >1.5 cm; SPD** decrease >75%
indeterminate bone marrow
LN: lymph nodes or nodal masses ** SPD: sum of the products of the greatest diameters
measure: Overall Response Rate (Antitumor Effect: PR or Better) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC)
time frame: Up to 30 weeks
description: The criteria for PR based on IWRC are shown below.
PR: SPD regressed > 50%
measure: Complete Response Rate (CR) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC)
time frame: Up to 30 weeks
description: The criteria for CR based on the Revised RC are shown below.
Definition: Disappearance of all evidence of disease
Nodal Masses:
[18F]fluorodeoxyglucose (FDG)-avid or PET positive prior to therapy; mass of any size permitted if PET negative.
Variably FDG-avid or PET negative; regression to normal size on CT.
Spleen, Liver:
Not palpable, nodules disappeared
Bone Marrow:
Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative.
measure: Overall Response Rate (PR or Better) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC)
time frame: Up to 30 weeks
description: The criteria for PR based on the Revised RC are shown below.
Definition: Regression of measurable disease and no new sites
Nodal Masses:
50% or more decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes
FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site
Variably FDG-avid or PET negative; regression on CT
Spleen, Liver:
50% or more decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen
Bone Marrow:
Irrelevant if positive prior to therapy; cell type should be specified.
measure: Complete Response Rate Based on WHO Handbook for Reporting Results of Cancer Treatment (1979)
time frame: Up to 30 weeks
description: The criteria for Complete response based on WHO Handbook for Reporting Results of Cancer Treatment (1979) are shown below.
Measurable disease:
The disappearance of all known disease, determined by 2 observations not less than 4 weeks apart.
Unmeasurable disease:
Complete disappearance of all known disease for at least 4 weeks.
Bone metastases:
Complete disappearance of all lesions on X-ray or scan for at least 4 weeks.
measure: Overall Response Rate (PR or Better) Based on "WHO Handbook for Reporting Results of Cancer Treatment (1979)"
time frame: Up to 30 weeks
description: The criteria for Overall response rate (PR or better) based on "WHO Handbook for Reporting Results of Cancer Treatment (1979)" are shown below.
Definition of PR:
Measurable disease:
50% or more decrease in total tumor size of the lesions which have been measured to determine the effect of therapy by 2 observations not less than 4 weeks apart. In addition there can be no appearance of new lesions or progression of any lesion.
Unmeasurable disease:
Estimated decrease in tumor size of 50% or more for at least 4 weeks.
Bone metastases:
Partial decrease in size of lytic lesions, recalcification of lytic lesions, or decreased density of blastic lesions for at least 4 weeks.
measure: Progression-Free Survival (PFS)
time frame: Up to 30 weeks
description: PFS is the period from registration date to the earliest onset date of any progression event calculated using the Kaplan-Meier estimator. The median and the 95% confidence interval (CI) were calculated using Greenwood's formula.
Progression event was defined as progression (includes recurrence/relapse), initiation of post-study treatment, confirmation of other malignant tumor, or death due to any given cause. The date of progression was determined based on overall response assessed using IWRC, Revised RC, and WHO, and assessment by the primary physicians (excluding overall response).
measure: Duration of Response (DOR)
time frame: Up to 30 weeks
description: DOR is the period from the date of achieving CR, CRu or PR in the responders to the earliest onset date of any progression events calculated using the Kaplan-Meier estimator. The median and the 95% CI were calculated using Greenwood's formula.
The date of achieving CR, CRu or PR was determined based on the overall response assessed using IWRC. The date of progression was determined based on overall response assessed using IWRC, Revised RC and WHO, and assessment by the primary physicians (excluding overall response).
Progression event was defined as progression (includes recurrence/relapse), initiation of post-study treatment, confirmation of other malignant tumor, or death due to any given cause.
measure: Overall Survival (OS)
time frame: Up to 30 weeks
description: Death due to any given cause was defined as an event. OS was calculated using the Kaplan-Meier estimator. The median and the 95% CI were calculated using Greenwood's formula.
measure: Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Discontinuation Due to Adverse Event
time frame: up to 30 weeks
description: Adverse events were evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.0, Japan Clinical Oncology Group/Japan Society of Clinical Oncology (JCOG/JSCO) version, and were encoded using Medical Dictionary for Regulatory Activities (MedDRA) Ver.16.1.
measure: Laboratory Test Abnormalities (Biochemical Tests)
time frame: up to 30 weeks
description: Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE. Grade 1 : mild Grade 2 : moderate Grade 3 : severe or medically significant but not immediately life-threatening Grade 4 : life threatening or disabling Grade 5 : death related to AE
measure: Laboratory Test Abnormalities (Hematology Tests)
time frame: up to 30 weeks
description: Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE. Grade 1 : mild Grade 2 : moderate Grade 3 : severe or medically significant but not immediately life-threatening Grade 4 : life threatening or disabling Grade 5 : death related to AE
arm group label: SyB L-0501＋rituximab
arm group type: Experimental
intervention type: Drug
intervention name: SyB L-0501
description: A dose of 90 mg/m^2/day of SyB L-0501 is administered on Day 1 and Day 2 as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times.
arm group label: SyB L-0501＋rituximab
intervention type: Drug
intervention name: rituximab
description: A dose of 375 mg/m^2 of rituximab is administered on Day 1 (Day 0 in Cycle 1 only) as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times. From Cycle 2, rituximab will be coadministered with SyB L-0501 on Day 1. However, if the investigator or sub-investigator judges that the coadministration is difficult, rituximab may be administered on Day 0.
arm group label: SyB L-0501＋rituximab
criteria: 
gender: All
minimum age: 20 Years
maximum age: 79 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin
mesh term: Lymphoma, Mantle-Cell
mesh term: Lymphoma, B-Cell
mesh term: Rituximab
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 