<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/NCT01680991</url>
  </required_header>
  <id_info>
    <org_study_id>YP25623</org_study_id>
    <nct_id>NCT01680991</nct_id>
  </id_info>
  <brief_title>A Study of Obinutuzumab in Chinese Participants With CD20+ Malignant Disease</brief_title>
  <official_title>A Multi-Center, Open Label, Single Arm, Multiple Dose Study to Assess the Pharmacokinetics of RO5072759 in Chinese Patients With CD20+ Malignant Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This multi-center, open-label, single-arm study will evaluate the pharmacokinetics and safety&#xD;
      of obinutuzumab in participants with cluster of differentiation (CD) 20 positive (+)&#xD;
      malignant disease. Participants will receive multiple doses of obinutuzumab. The anticipated&#xD;
      time on study treatment is 24 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under the Serum Concentration Time Curve From Zero to Day 7 (AUC0-7) of Obinutuzumab on Day 1, Cycle 1</measure>
    <time_frame>Cycle 1-NHL: within 2 hours (h) pre-dose (Pr-D), end of infusion (EoI), 4, 24, 72 and 120 h post-infusion (Po-I) on Day 1; CLL: within 2 h Pr-D, EoI on Days 1,2; 4, 24, 72 and 120 h Po-I on Day 2. NHL and CLL: within 2 h Pr-D on Day 8</time_frame>
    <description>DLBCL and FL are sub-types of Non-Hodgkin's Lymphoma (NHL) and time frame for these 2 groups was presented under NHL. For CLL, pharmacokinetic (PK) parameters were from Cycle 1 Day 1 and Day 2 dosing, due to split dosing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Serum Concentration (Cmax) of Obinutuzumab on Day 1, Cycle 1</measure>
    <time_frame>Cycle 1-NHL: within 2 h Pr-D, EoI, 4, 24, 72 and 120 h Po-I on Day 1; CLL: within 2 h Pr-D, EoI on Days 1,2; 4, 24, 72 and 120 h Po-I on Day 2. NHL and CLL: within 2 h Pr-D on Day 8</time_frame>
    <description>DLBCL and FL are sub-types of NHL and time frame for these 2 groups was presented under NHL. For CLL, PK parameters were from Cycle 1 Day 1 and Day 2 dosing, due to split dosing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Serum Concentration Versus Time Curve From 0 to Day 21 (AUC0-21) of Obinutuzumab at Cycle 8</measure>
    <time_frame>Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Obinutuzumab at Cycle 8</measure>
    <time_frame>Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Maximum Observed Serum Concentration (Tmax) of Obinutuzumab at Cycle 8</measure>
    <time_frame>Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Terminal Half-life (t1/2)</measure>
    <time_frame>Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1, 4-week follow-up (Day 29), 3 and 6 months after Cycle 8 dosing</time_frame>
    <description>Half-life is the time measured for the serum concentration of study drug to decrease (Dec) by one half.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of Distribution at Steady State (Vss) of Obinutuzumab at Cycle 8</measure>
    <time_frame>Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1</time_frame>
    <description>Vss reflects the actual blood and tissue volume into which a drug is distributed and the relative binding of drug to protein in these spaces.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Systemic Clearance at Steady State (CLss) of Obinutuzumab at Cycle 8</measure>
    <time_frame>Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1</time_frame>
    <description>Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum Observed Serum Concentration of Obinutuzumab</measure>
    <time_frame>Within 2 hours Pr-D on Day 1 of Cycles 2-8 and on Days 8,15 of Cycle 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Complete Response (CR), CR Unconfirmed (CRu) at End of Treatment (1 Month After Cycle 8) in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria</measure>
    <time_frame>1 month after the last dose (received on Day 148) of study drug</time_frame>
    <description>CR: 1) Disappearance of clinical and radiographic evidence of disease, related symptoms and normalization of biochemical abnormalities definitely assignable to NHL, 2) Lymph nodes (LN) and nodal masses regressed to normal size after therapy (AT) (≤1.5 centimeters [cm] in their greatest transverse diameter [GTD] for LN greater than (&gt;) 1.5 cm before therapy [BT]). LN that were 1.1 to 1.5 cm in their GTD BT decreased to ≤1 cm in GTD AT, or &gt;75% in the sum of the products (SPD) of the GTD, 3) Enlarged spleen regressed in size and not palpable, 4) Absence of macroscopic nodules, 5) Enlarged organs decreased in size, and 6) If the bone marrow (BM) was involved, the infiltrate must be cleared on repeat BM aspirate and biopsy. CRu included those participants who met CR Criteria 1 and 3, but with 1 or more of the following features: a) A residual LN mass &gt;1.5 cm in GTD that has regressed by more than 75% in their SPD, and b) Indeterminate BM (increased [Inc] number or size of aggregates).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) at End of Treatment (1 Month After Cycle 8) in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria</measure>
    <time_frame>1 month after the last dose (received on Day 148) of study drug</time_frame>
    <description>PR: 1) ≥50% decrease in SPD of the 6 largest dominant nodes/nodal masses. These nodes or masses selected according to the following features: a) clearly measurable in ≥2 perpendicular dimensions, b) from as disparate regions of the body as possible, and c) included mediastinal and retroperitoneal areas of disease. 2) No increase in size of other nodes (liver/spleen). 3) Splenic and hepatic nodules regressed by ≥50% in SPD. 4) With exception of splenic and hepatic nodules, involvement of other organs was considered assessable and not measurable disease. 5) BM assessment is irrelevant for determination of a PR because it was assessable and not measurable disease; however, if positive, the cell type was specified. 6) No new sites of disease. PD requires the following: 1) ≥50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders. 2) Appearance of any new lesion during or at the end of therapy. SD is defined as less than a PR but not PD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Best Overall Response (BOR) of CR, CRu at Anytime During Study in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria</measure>
    <time_frame>From screening to up to 1 month after the last dose (received on Day 148) of study drug</time_frame>
    <description>CR: 1) Disappearance of clinical and radiographic evidence of disease, related symptoms and normalization of biochemical abnormalities definitely assignable to NHL, 2) LN and nodal masses regressed to normal size AT (≤1.5 cm] in their GTD for LN &gt;1.5 cm BT). LN that were 1.1 to 1.5 cm in their GTD BT decreased to ≤1 cm in GTD AT, or &gt;75% in the SPD of the GTD, 3) Enlarged spleen regressed in size and not palpable, 4) Absence of macroscopic nodules in any organs, 5) Enlarged organs decreased in size, and 6) If the BM was involved, the infiltrate must be cleared on repeat BM aspirate and biopsy. CRu included those participants who met CR Criteria 1 and 3, but with 1 or more of the following features: a) A residual LN mass &gt;1.5 cm in GTD that has regressed by more than 75% in their SPD, b) Indeterminate BM (increased number or size of aggregates).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With BOR of PR, SD, and PD at Anytime During Study in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria</measure>
    <time_frame>From screening to up to 1 month after the last dose (received on Day 148) of study drug</time_frame>
    <description>PR: 1) ≥50% decrease in SPD of the 6 largest dominant nodes/nodal masses. These nodes or masses selected according to the following features: a) clearly measurable in ≥2 perpendicular dimensions, b) from as disparate regions of the body as possible, and c) included mediastinal and retroperitoneal areas of disease. 2) No increase in size of other nodes (liver/spleen). 3) Splenic and hepatic nodules regressed by ≥50% in SPD. 4) With exception of splenic and hepatic nodules, involvement of other organs was considered assessable and not measurable disease. 5) BM assessment is irrelevant for determination of a PR because it was assessable and not measurable disease; however, if positive, the cell type was specified. 6) No new sites of disease. PD requires the following: 1) ≥50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders. 2) Appearance of any new lesion during or at the end of therapy. SD is defined as less than a PR but not PD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Complete Remission (CRe), CRe With Incomplete BM Recovery (CRi) at End of Treatment (1 Month After Cycle 8) in CLL Participants According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Guidelines</measure>
    <time_frame>2 months after the last dose (received on Day 148) of study drug</time_frame>
    <description>CRe required the following criteria as assessed, at least 2 months from completing therapy: a) peripheral blood lymphocytes (PBL) less than (&lt;) 4 x 10^9/L, b) Absence of significant lymphadenopathy (LD) by physical examination (PE), c) No hepatomegaly/splenomegaly (HM/SM) by PE, d) Absence of constitutional symptoms and e) Blood counts above the following values (i. Neutrophils [Neu] &gt;1.5 x 10^9/L without the need for exogenous growth factors [EGF], ii. Platelets (Plt) &gt;100 x 10^9/L without the need for EGF, and iii. Hemoglobin (Hb) &gt;11.0 g/dL without blood transfusion or need for erythropoietin), and d) Once clinical and laboratory reports demonstrated CRe, a BM aspirate and biopsy was performed at least 2 months after the last treatment; to define a CRe, BM sample should be normocellular for age, &lt;30% of the cells being PBL and lymphoid nodules absent. CRi: CRe but persistent anemia/thrombocytopenia/neutropenia unrelated to CLL, but related to drug toxicity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With PR, SD, and PD at End of Treatment (1 Month After Cycle 8) in CLL Participants According to IWCLL 2008 Guidelines</measure>
    <time_frame>2 months after the last dose (received on Day 148) of study drug</time_frame>
    <description>Group A: a)Dec LN size by ≥50% either in SPD of 6 LN or largest diameter of enlarged LN (ELN) detected BT, b)Reduction (Red) in BT enlargement of liver, c)Red in BT enlargement of spleen, d)Dec in PBL by ≥50% from baseline, e)A 50% Red in BM infiltrate or B-lymphoid nodules in BM and f)No Inc in any LN and no new ELN. Group B: a)Plt count=100,000/µL or Inc of ≥50% over baseline, b)Hb &gt;11 g/dL or ≥50% Inc over baseline, c)Neu &gt; 1500/µL or &gt; 50% Inc over baseline. PR is considered as achieved if 2 of Group A criteria and 1 of Group B criteria were met for ≥2 months. PD is defined as LD (appearance of new lesion [ELN], SM, HM or other organ infiltrates) or Inc by ≥50% in greatest determined diameter of any previous site or Inc in previously noted enlargement of liver/spleen by ≥50% or new appearance of HM/SM or an Inc in number of PBL ≥50% or transformation to a more aggressive histology or occurrence of cytopenia attributable to CLL. SD is defined as less than a PR but is not PD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With BOR of CRe, CRi at Anytime During the Study in CLL Participants According to IWCLL 2008 Guidelines</measure>
    <time_frame>From screening to up to 2 months after the last dose (received on Day 148) of study drug</time_frame>
    <description>CRe required the following criteria as assessed, at least 2 months from completing therapy: a) PBL &lt;4 x 10^9/L, b) Absence of significant LD by PE, c) No HM/SM by PE, d) Absence of constitutional symptoms and e) Blood counts above the following values (i. Neu &gt;1.5 x 10^9/L without the need for EGF, ii. Plt &gt;100 x 10^9/L without the need for EGF, and iii. Hb &gt;11.0 g/dL without blood transfusion or need for EGF, and d) Once clinical and laboratory reports demonstrated CRe, a BM aspirate and biopsy was performed at least 2 months after the last treatment; to define a CRe, BM sample should be normocellular for age, &lt;30% of the cells being PBL and lymphoid nodules absent. CRi: CRe but persistent anemia/thrombocytopenia/neutropenia unrelated to CLL, but related to drug toxicity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With BOR of PR, SD, and PD at Anytime During Study in CLL Participants According to IWCLL 2008 Guidelines</measure>
    <time_frame>From screening to up to 2 months after the last dose (received on Day 148) of study drug</time_frame>
    <description>Group A: a)Dec LN size by ≥50% either in SPD of 6 LN or largest diameter of ELN detected BT, b)Red in BT enlargement of liver, c)Red in BT enlargement of spleen, d)Dec in PBL by ≥50% from baseline, e)A 50% Red in BM infiltrate or B-lymphoid nodules in BM and f)No Inc in any LN and no new ELN. Group B: a)Plt count=100,000/µL or Inc of ≥50% over baseline, b)Hb &gt;11 g/dL or ≥50% Inc over baseline, c)Neu &gt; 1500/µL or &gt; 50% Inc over baseline. PR is considered as achieved if 2 of Group A criteria and 1 of Group B criteria were met for ≥2 months. PD is defined as LD (appearance of new lesion [ELN], SM, HM or other organ infiltrates) or Inc by ≥50% in greatest determined diameter of any previous site or Inc in previously noted enlargement of liver/spleen by ≥50% or new appearance of HM/SM or an Inc in number of PBL ≥50% or transformation to a more aggressive histology or occurrence of cytopenia attributable to CLL. SD is defined as less than a PR but is not PD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Positive Human Anti-Human Antibodies (HAHA)</measure>
    <time_frame>Cycle 1 (Day 1), Cycle 4 (Day 1), 4-week follow-up, 3 and 6 month follow-up</time_frame>
    <description>For the detection of HAHA, serum samples were initially analyzed using a validated enzyme linked immunosorbent assay (ELISA) method (screening assay, tier 1). The lower limit of quantification (LLOQ) in undiluted serum was 18.4 nanograms per milliliter (ng/mL). The precision ranged from 4.85 percent (%) to 16.0%. In serum samples found positive, the presence of specific anti-obinutuzumab antibodies was confirmed or excluded using the same ELISA method with an appropriate immunocompetition step (addition of excess obinutuzumab, confirmation assay, tier 2). Samples were confirmed as containing specific anti-obinutuzumab antibodies if there was a signal reduction ≥85.7% in the presence of obinutuzumab.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Positive Human Anti-Chimeric Antibodies (HACA)</measure>
    <time_frame>Cycle 1, Day 1</time_frame>
    <description>Serum concentrations of HACA against rituximab were determined by ELISA. The LLOQ in undiluted serum was 5.00 relative units per milliliter (RU/mL). The precision and accuracy of the assay, as determined from the analysis of quality control samples, were satisfactory throughout the study; precision ranged from 6.4% to 13.6% and accuracy ranged from 88.2% to 94.8%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With B-cell Depletion or Recovery</measure>
    <time_frame>Screening, Cycle 1 (Days 1,8), Cycle 2 (Day 1), Cycle 4 (Day 1), Cycle 6 (Day 1), Cycle 8 (Day 1), 4 weeks after last dose of study drug and every 3 months after last dose of study drug up to 1 year</time_frame>
    <description>Depletion is defined as cluster of differentiation (CD) 19+ B-cell count &lt;0.07 x10^9/L.Recovery is defined as CD19+ B-cell equal to or greater than 0.07 x 10^9/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Depletion of CD19+ B-cell</measure>
    <time_frame>Screening, Cycle 1 (Days 1,8), Cycle 2 (Day 1), Cycle 4 (Day 1), Cycle 6 (Day 1), Cycle 8 (Day 1), 4 weeks after last dose of study drug and every 3 months after last dose of study drug up to 1 year</time_frame>
    <description>Depletion is defined as CD19+ B-cell count &lt; 0.07 x 10^9/L. The duration of depletion is defined as the number of days between first assessment of B-cell depletion and the first assessment where CD19+ cell count returned to at least the depletion level from baseline and not followed by any further B-cell depletion. If participant did not return to above depletion level, then the cut off is at the time of last assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Recovery of CD19+ B-cell</measure>
    <time_frame>Screening, Cycle 1 (Days 1,8), Cycle 2 (Day 1), Cycle 4 (Day 1), Cycle 6 (Day 1), Cycle 8 (Day 1), 4 weeks after last dose of study drug and every 3 months after last dose of study drug up to 1 year</time_frame>
    <description>Recovery is defined as CD19+ B-cell equal to or greater than 0.07 x 10^9/L. Time to recovery is defined as time between the beginning of depletion and first value after end of treatment that is equal or above 0.07x10^9/L and not exclusively followed by depleted values only. If participant did not return to above recovery level then set to Null.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Lymphocytic Leukemia, Chronic, Diffuse Large B-cell Lymphoma, Follicular Lymphoma</condition>
  <arm_group>
    <arm_group_label>CLL: 1000 mg Obinutuzumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with chronic lymphocytic leukemia (CLL) will receive 1000 milligrams (mg) obinutuzumab as an intravenous (IV) infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. The first infusion on Cycle 1 Day 1 will be given over two days: Day 1 and Day 2. Additional doses of obinutuzumab will be administered on Cycle 1 Day 8 and Day 15.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DLBCL: 1000 mg Obinutuzumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with diffuse large B-cell lymphoma (DLBCL) will receive 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab will be administered on Cycle 1 Day 8 and Day 15.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FL: 1000 mg Obinutuzumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with follicular lymphoma (FL) will receive 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab will be administered on Cycle 1 Day 8 and Day 15.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Obinutuzumab</intervention_name>
    <description>Multiple doses of obinutuzumab.</description>
    <arm_group_label>CLL: 1000 mg Obinutuzumab</arm_group_label>
    <arm_group_label>DLBCL: 1000 mg Obinutuzumab</arm_group_label>
    <arm_group_label>FL: 1000 mg Obinutuzumab</arm_group_label>
    <other_name>RO5072759</other_name>
    <other_name>GA101</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of CD20+ B-cell lymphoma or B-CLL&#xD;
&#xD;
          -  Refractory/relapsed CLL, FL, and DLBCL&#xD;
&#xD;
          -  At least 1 measurable lesion (greater than [&gt;] 1.5 centimeters [cm] in its largest&#xD;
             dimension) with the exception of CLL&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1&#xD;
&#xD;
          -  Life expectancy &gt;6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior use of any investigational antibody therapy within 6 months of study start&#xD;
&#xD;
          -  Prior use of any anti-cancer vaccine&#xD;
&#xD;
          -  Prior administration of rituximab within 3 months of study start&#xD;
&#xD;
          -  Prior administration of radioimmunotherapy 3 months prior to study entry&#xD;
&#xD;
          -  Central nervous system lymphoma&#xD;
&#xD;
          -  History of other malignancy&#xD;
&#xD;
          -  Evidence of significant, uncontrolled concomitant disease&#xD;
&#xD;
          -  Abnormal laboratory values&#xD;
&#xD;
          -  Patients with progressive multifocalleukoencephalopathy (PML)&#xD;
&#xD;
          -  Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Beijing</city>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Beijing</city>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Shanghai</city>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <results_first_submitted>March 23, 2016</results_first_submitted>
  <results_first_submitted_qc>March 23, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 25, 2016</results_first_posted>
  <last_update_submitted>March 23, 2016</last_update_submitted>
  <last_update_submitted_qc>March 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 25, 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, Follicular</mesh_term>
    <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
    <mesh_term>Leukemia, Lymphocytic, Chronic, B-Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obinutuzumab</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>CLL: 1000 mg Obinutuzumab</title>
          <description>Participants with chronic lymphocytic leukemia (CLL) received 1000 milligrams (mg) obinutuzumab as an intravenous (IV) infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.</description>
        </group>
        <group group_id="P2">
          <title>DLBCL: 1000 mg Obinutuzumab</title>
          <description>Participants with diffuse large B-cell lymphoma (DLBCL) received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
        </group>
        <group group_id="P3">
          <title>FL: 1000 mg Obinutuzumab</title>
          <description>Participants with follicular lymphoma (FL) received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="23"/>
                <participants group_id="P3" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="19"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive disease (PD)</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Bad physical condition</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>PD confirmed in other hospital</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety analysis population included all participants who received at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>CLL: 1000 mg Obinutuzumab</title>
          <description>Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.</description>
        </group>
        <group group_id="B2">
          <title>DLBCL: 1000 mg Obinutuzumab</title>
          <description>Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
        </group>
        <group group_id="B3">
          <title>FL: 1000 mg Obinutuzumab</title>
          <description>Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
            <count group_id="B2" value="23"/>
            <count group_id="B3" value="13"/>
            <count group_id="B4" value="48"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.7" spread="12.0"/>
                    <measurement group_id="B2" value="53.3" spread="15.8"/>
                    <measurement group_id="B3" value="55.1" spread="8.8"/>
                    <measurement group_id="B4" value="55.6" spread="13.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Serum Concentration Time Curve From Zero to Day 7 (AUC0-7) of Obinutuzumab on Day 1, Cycle 1</title>
        <description>DLBCL and FL are sub-types of Non-Hodgkin's Lymphoma (NHL) and time frame for these 2 groups was presented under NHL. For CLL, pharmacokinetic (PK) parameters were from Cycle 1 Day 1 and Day 2 dosing, due to split dosing.</description>
        <time_frame>Cycle 1-NHL: within 2 hours (h) pre-dose (Pr-D), end of infusion (EoI), 4, 24, 72 and 120 h post-infusion (Po-I) on Day 1; CLL: within 2 h Pr-D, EoI on Days 1,2; 4, 24, 72 and 120 h Po-I on Day 2. NHL and CLL: within 2 h Pr-D on Day 8</time_frame>
        <population>PK analysis population included all participants who received at least 1 dose of study drug and had serum concentrations available. Here, number of participants analyzed = participants who were evaluable for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>CLL: 1000 mg Obinutuzumab</title>
            <description>Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.</description>
          </group>
          <group group_id="O2">
            <title>DLBCL: 1000 mg Obinutuzumab</title>
            <description>Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
          <group group_id="O3">
            <title>FL: 1000 mg Obinutuzumab</title>
            <description>Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Serum Concentration Time Curve From Zero to Day 7 (AUC0-7) of Obinutuzumab on Day 1, Cycle 1</title>
          <description>DLBCL and FL are sub-types of Non-Hodgkin's Lymphoma (NHL) and time frame for these 2 groups was presented under NHL. For CLL, pharmacokinetic (PK) parameters were from Cycle 1 Day 1 and Day 2 dosing, due to split dosing.</description>
          <population>PK analysis population included all participants who received at least 1 dose of study drug and had serum concentrations available. Here, number of participants analyzed = participants who were evaluable for this outcome.</population>
          <units>day*micrograms per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1458" spread="34.8"/>
                    <measurement group_id="O2" value="1750" spread="20.5"/>
                    <measurement group_id="O3" value="1647" spread="20.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Observed Serum Concentration (Cmax) of Obinutuzumab on Day 1, Cycle 1</title>
        <description>DLBCL and FL are sub-types of NHL and time frame for these 2 groups was presented under NHL. For CLL, PK parameters were from Cycle 1 Day 1 and Day 2 dosing, due to split dosing.</description>
        <time_frame>Cycle 1-NHL: within 2 h Pr-D, EoI, 4, 24, 72 and 120 h Po-I on Day 1; CLL: within 2 h Pr-D, EoI on Days 1,2; 4, 24, 72 and 120 h Po-I on Day 2. NHL and CLL: within 2 h Pr-D on Day 8</time_frame>
        <population>PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>CLL: 1000 mg Obinutuzumab</title>
            <description>Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.</description>
          </group>
          <group group_id="O2">
            <title>DLBCL: 1000 mg Obinutuzumab</title>
            <description>Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
          <group group_id="O3">
            <title>FL: 1000 mg Obinutuzumab</title>
            <description>Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Serum Concentration (Cmax) of Obinutuzumab on Day 1, Cycle 1</title>
          <description>DLBCL and FL are sub-types of NHL and time frame for these 2 groups was presented under NHL. For CLL, PK parameters were from Cycle 1 Day 1 and Day 2 dosing, due to split dosing.</description>
          <population>PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.</population>
          <units>micrograms per milliliter (mcg/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="369" spread="31.8"/>
                    <measurement group_id="O2" value="442" spread="21.1"/>
                    <measurement group_id="O3" value="437" spread="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Serum Concentration Versus Time Curve From 0 to Day 21 (AUC0-21) of Obinutuzumab at Cycle 8</title>
        <time_frame>Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1</time_frame>
        <population>PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>CLL: 1000 mg Obinutuzumab</title>
            <description>Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.</description>
          </group>
          <group group_id="O2">
            <title>DLBCL: 1000 mg Obinutuzumab</title>
            <description>Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
          <group group_id="O3">
            <title>FL: 1000 mg Obinutuzumab</title>
            <description>Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Serum Concentration Versus Time Curve From 0 to Day 21 (AUC0-21) of Obinutuzumab at Cycle 8</title>
          <population>PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.</population>
          <units>day*mcg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12289" spread="42.7"/>
                    <measurement group_id="O2" value="13000" spread="37.3"/>
                    <measurement group_id="O3" value="11285" spread="26.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax of Obinutuzumab at Cycle 8</title>
        <time_frame>Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1</time_frame>
        <population>PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>CLL: 1000 mg Obinutuzumab</title>
            <description>Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.</description>
          </group>
          <group group_id="O2">
            <title>DLBCL: 1000 mg Obinutuzumab</title>
            <description>Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
          <group group_id="O3">
            <title>FL: 1000 mg Obinutuzumab</title>
            <description>Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax of Obinutuzumab at Cycle 8</title>
          <population>PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.</population>
          <units>mcg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1050" spread="32.6"/>
                    <measurement group_id="O2" value="966" spread="28.3"/>
                    <measurement group_id="O3" value="867" spread="19.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Maximum Observed Serum Concentration (Tmax) of Obinutuzumab at Cycle 8</title>
        <time_frame>Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1</time_frame>
        <population>PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>CLL: 1000 mg Obinutuzumab</title>
            <description>Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.</description>
          </group>
          <group group_id="O2">
            <title>DLBCL: 1000 mg Obinutuzumab</title>
            <description>Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
          <group group_id="O3">
            <title>FL: 1000 mg Obinutuzumab</title>
            <description>Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Maximum Observed Serum Concentration (Tmax) of Obinutuzumab at Cycle 8</title>
          <population>PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" lower_limit="3.3" upper_limit="25.5"/>
                    <measurement group_id="O2" value="7.25" lower_limit="3.3" upper_limit="27.5"/>
                    <measurement group_id="O3" value="4.0" lower_limit="3.2" upper_limit="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Terminal Half-life (t1/2)</title>
        <description>Half-life is the time measured for the serum concentration of study drug to decrease (Dec) by one half.</description>
        <time_frame>Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1, 4-week follow-up (Day 29), 3 and 6 months after Cycle 8 dosing</time_frame>
        <population>PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>CLL: 1000 mg Obinutuzumab</title>
            <description>Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.</description>
          </group>
          <group group_id="O2">
            <title>DLBCL: 1000 mg Obinutuzumab</title>
            <description>Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
          <group group_id="O3">
            <title>FL: 1000 mg Obinutuzumab</title>
            <description>Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Terminal Half-life (t1/2)</title>
          <description>Half-life is the time measured for the serum concentration of study drug to decrease (Dec) by one half.</description>
          <population>PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.</population>
          <units>day</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.5" spread="71.8"/>
                    <measurement group_id="O2" value="33.3" spread="68.6"/>
                    <measurement group_id="O3" value="26.7" spread="49.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Volume of Distribution at Steady State (Vss) of Obinutuzumab at Cycle 8</title>
        <description>Vss reflects the actual blood and tissue volume into which a drug is distributed and the relative binding of drug to protein in these spaces.</description>
        <time_frame>Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1</time_frame>
        <population>PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>CLL: 1000 mg Obinutuzumab</title>
            <description>Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.</description>
          </group>
          <group group_id="O2">
            <title>DLBCL: 1000 mg Obinutuzumab</title>
            <description>Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
          <group group_id="O3">
            <title>FL: 1000 mg Obinutuzumab</title>
            <description>Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Volume of Distribution at Steady State (Vss) of Obinutuzumab at Cycle 8</title>
          <description>Vss reflects the actual blood and tissue volume into which a drug is distributed and the relative binding of drug to protein in these spaces.</description>
          <population>PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.</population>
          <units>Liter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.32" spread="27.9"/>
                    <measurement group_id="O2" value="4.49" spread="38.2"/>
                    <measurement group_id="O3" value="4.03" spread="21.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Systemic Clearance at Steady State (CLss) of Obinutuzumab at Cycle 8</title>
        <description>Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.</description>
        <time_frame>Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1</time_frame>
        <population>PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>CLL: 1000 mg Obinutuzumab</title>
            <description>Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.</description>
          </group>
          <group group_id="O2">
            <title>DLBCL: 1000 mg Obinutuzumab</title>
            <description>Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
          <group group_id="O3">
            <title>FL: 1000 mg Obinutuzumab</title>
            <description>Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Systemic Clearance at Steady State (CLss) of Obinutuzumab at Cycle 8</title>
          <description>Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.</description>
          <population>PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.</population>
          <units>mL/day</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.4" spread="42.7"/>
                    <measurement group_id="O2" value="76.9" spread="37.3"/>
                    <measurement group_id="O3" value="88.6" spread="26.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Minimum Observed Serum Concentration of Obinutuzumab</title>
        <time_frame>Within 2 hours Pr-D on Day 1 of Cycles 2-8 and on Days 8,15 of Cycle 1</time_frame>
        <population>PK population. Here, number of participants analyzed = participants who were evaluable for this outcome and &quot;n&quot; is the number of participants evaluable at the specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>CLL: 1000 mg Obinutuzumab</title>
            <description>Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.</description>
          </group>
          <group group_id="O2">
            <title>DLBCL: 1000 mg Obinutuzumab</title>
            <description>Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
          <group group_id="O3">
            <title>FL: 1000 mg Obinutuzumab</title>
            <description>Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Minimum Observed Serum Concentration of Obinutuzumab</title>
          <population>PK population. Here, number of participants analyzed = participants who were evaluable for this outcome and &quot;n&quot; is the number of participants evaluable at the specified time point.</population>
          <units>mcg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1-Day 8 (n=11,22,13)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="156" spread="57.2"/>
                    <measurement group_id="O2" value="186" spread="25.2"/>
                    <measurement group_id="O3" value="148" spread="39.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 1-Day 15 (n=11,22,13)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="282" spread="69.4"/>
                    <measurement group_id="O2" value="350" spread="23.7"/>
                    <measurement group_id="O3" value="284" spread="26.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2 (n=11,21,13)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="389" spread="71.2"/>
                    <measurement group_id="O2" value="458" spread="26.3"/>
                    <measurement group_id="O3" value="433" spread="31.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 3 (n=10,18,13)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="260" spread="246"/>
                    <measurement group_id="O2" value="367" spread="49.6"/>
                    <measurement group_id="O3" value="346" spread="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 4 (n=10,14,13)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="232" spread="279.7"/>
                    <measurement group_id="O2" value="370" spread="49.2"/>
                    <measurement group_id="O3" value="346" spread="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5 (n=9,11,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="299" spread="91.2"/>
                    <measurement group_id="O2" value="412" spread="42"/>
                    <measurement group_id="O3" value="396" spread="44.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 6 (n=9,10,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="317" spread="93.5"/>
                    <measurement group_id="O2" value="425" spread="38.2"/>
                    <measurement group_id="O3" value="361" spread="40.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 7 (n=9,10,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="358" spread="80.6"/>
                    <measurement group_id="O2" value="367" spread="40.3"/>
                    <measurement group_id="O3" value="375" spread="41.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 8 (n=9,8,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="403" spread="85.3"/>
                    <measurement group_id="O2" value="455" spread="45.4"/>
                    <measurement group_id="O3" value="352" spread="38.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Complete Response (CR), CR Unconfirmed (CRu) at End of Treatment (1 Month After Cycle 8) in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria</title>
        <description>CR: 1) Disappearance of clinical and radiographic evidence of disease, related symptoms and normalization of biochemical abnormalities definitely assignable to NHL, 2) Lymph nodes (LN) and nodal masses regressed to normal size after therapy (AT) (≤1.5 centimeters [cm] in their greatest transverse diameter [GTD] for LN greater than (&gt;) 1.5 cm before therapy [BT]). LN that were 1.1 to 1.5 cm in their GTD BT decreased to ≤1 cm in GTD AT, or &gt;75% in the sum of the products (SPD) of the GTD, 3) Enlarged spleen regressed in size and not palpable, 4) Absence of macroscopic nodules, 5) Enlarged organs decreased in size, and 6) If the bone marrow (BM) was involved, the infiltrate must be cleared on repeat BM aspirate and biopsy. CRu included those participants who met CR Criteria 1 and 3, but with 1 or more of the following features: a) A residual LN mass &gt;1.5 cm in GTD that has regressed by more than 75% in their SPD, and b) Indeterminate BM (increased [Inc] number or size of aggregates).</description>
        <time_frame>1 month after the last dose (received on Day 148) of study drug</time_frame>
        <population>Safety analysis population. Data reported only for DLBCL and FL arm groups.</population>
        <group_list>
          <group group_id="O1">
            <title>DLBCL: 1000 mg Obinutuzumab</title>
            <description>Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
          <group group_id="O2">
            <title>FL: 1000 mg Obinutuzumab</title>
            <description>Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Complete Response (CR), CR Unconfirmed (CRu) at End of Treatment (1 Month After Cycle 8) in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria</title>
          <description>CR: 1) Disappearance of clinical and radiographic evidence of disease, related symptoms and normalization of biochemical abnormalities definitely assignable to NHL, 2) Lymph nodes (LN) and nodal masses regressed to normal size after therapy (AT) (≤1.5 centimeters [cm] in their greatest transverse diameter [GTD] for LN greater than (&gt;) 1.5 cm before therapy [BT]). LN that were 1.1 to 1.5 cm in their GTD BT decreased to ≤1 cm in GTD AT, or &gt;75% in the sum of the products (SPD) of the GTD, 3) Enlarged spleen regressed in size and not palpable, 4) Absence of macroscopic nodules, 5) Enlarged organs decreased in size, and 6) If the bone marrow (BM) was involved, the infiltrate must be cleared on repeat BM aspirate and biopsy. CRu included those participants who met CR Criteria 1 and 3, but with 1 or more of the following features: a) A residual LN mass &gt;1.5 cm in GTD that has regressed by more than 75% in their SPD, and b) Indeterminate BM (increased [Inc] number or size of aggregates).</description>
          <population>Safety analysis population. Data reported only for DLBCL and FL arm groups.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.00" upper_limit="14.82"/>
                    <measurement group_id="O2" value="0" lower_limit="0.00" upper_limit="24.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CRu</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" lower_limit="0.11" upper_limit="21.95"/>
                    <measurement group_id="O2" value="0" lower_limit="0.00" upper_limit="24.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) at End of Treatment (1 Month After Cycle 8) in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria</title>
        <description>PR: 1) ≥50% decrease in SPD of the 6 largest dominant nodes/nodal masses. These nodes or masses selected according to the following features: a) clearly measurable in ≥2 perpendicular dimensions, b) from as disparate regions of the body as possible, and c) included mediastinal and retroperitoneal areas of disease. 2) No increase in size of other nodes (liver/spleen). 3) Splenic and hepatic nodules regressed by ≥50% in SPD. 4) With exception of splenic and hepatic nodules, involvement of other organs was considered assessable and not measurable disease. 5) BM assessment is irrelevant for determination of a PR because it was assessable and not measurable disease; however, if positive, the cell type was specified. 6) No new sites of disease. PD requires the following: 1) ≥50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders. 2) Appearance of any new lesion during or at the end of therapy. SD is defined as less than a PR but not PD.</description>
        <time_frame>1 month after the last dose (received on Day 148) of study drug</time_frame>
        <population>Safety analysis population. Data reported only for DLBCL and FL arm groups.</population>
        <group_list>
          <group group_id="O1">
            <title>DLBCL: 1000 mg Obinutuzumab</title>
            <description>Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
          <group group_id="O2">
            <title>FL: 1000 mg Obinutuzumab</title>
            <description>Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) at End of Treatment (1 Month After Cycle 8) in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria</title>
          <description>PR: 1) ≥50% decrease in SPD of the 6 largest dominant nodes/nodal masses. These nodes or masses selected according to the following features: a) clearly measurable in ≥2 perpendicular dimensions, b) from as disparate regions of the body as possible, and c) included mediastinal and retroperitoneal areas of disease. 2) No increase in size of other nodes (liver/spleen). 3) Splenic and hepatic nodules regressed by ≥50% in SPD. 4) With exception of splenic and hepatic nodules, involvement of other organs was considered assessable and not measurable disease. 5) BM assessment is irrelevant for determination of a PR because it was assessable and not measurable disease; however, if positive, the cell type was specified. 6) No new sites of disease. PD requires the following: 1) ≥50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders. 2) Appearance of any new lesion during or at the end of therapy. SD is defined as less than a PR but not PD.</description>
          <population>Safety analysis population. Data reported only for DLBCL and FL arm groups.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7" lower_limit="1.07" upper_limit="28.04"/>
                    <measurement group_id="O2" value="46.2" lower_limit="19.22" upper_limit="74.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7" lower_limit="1.07" upper_limit="28.04"/>
                    <measurement group_id="O2" value="30.8" lower_limit="9.09" upper_limit="61.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.2" lower_limit="42.73" upper_limit="83.62"/>
                    <measurement group_id="O2" value="23.1" lower_limit="5.04" upper_limit="53.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Best Overall Response (BOR) of CR, CRu at Anytime During Study in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria</title>
        <description>CR: 1) Disappearance of clinical and radiographic evidence of disease, related symptoms and normalization of biochemical abnormalities definitely assignable to NHL, 2) LN and nodal masses regressed to normal size AT (≤1.5 cm] in their GTD for LN &gt;1.5 cm BT). LN that were 1.1 to 1.5 cm in their GTD BT decreased to ≤1 cm in GTD AT, or &gt;75% in the SPD of the GTD, 3) Enlarged spleen regressed in size and not palpable, 4) Absence of macroscopic nodules in any organs, 5) Enlarged organs decreased in size, and 6) If the BM was involved, the infiltrate must be cleared on repeat BM aspirate and biopsy. CRu included those participants who met CR Criteria 1 and 3, but with 1 or more of the following features: a) A residual LN mass &gt;1.5 cm in GTD that has regressed by more than 75% in their SPD, b) Indeterminate BM (increased number or size of aggregates).</description>
        <time_frame>From screening to up to 1 month after the last dose (received on Day 148) of study drug</time_frame>
        <population>Safety analysis population. Data reported only for DLBCL and FL arm groups.</population>
        <group_list>
          <group group_id="O1">
            <title>DLBCL: 1000 mg Obinutuzumab</title>
            <description>Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
          <group group_id="O2">
            <title>FL: 1000 mg Obinutuzumab</title>
            <description>Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Best Overall Response (BOR) of CR, CRu at Anytime During Study in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria</title>
          <description>CR: 1) Disappearance of clinical and radiographic evidence of disease, related symptoms and normalization of biochemical abnormalities definitely assignable to NHL, 2) LN and nodal masses regressed to normal size AT (≤1.5 cm] in their GTD for LN &gt;1.5 cm BT). LN that were 1.1 to 1.5 cm in their GTD BT decreased to ≤1 cm in GTD AT, or &gt;75% in the SPD of the GTD, 3) Enlarged spleen regressed in size and not palpable, 4) Absence of macroscopic nodules in any organs, 5) Enlarged organs decreased in size, and 6) If the BM was involved, the infiltrate must be cleared on repeat BM aspirate and biopsy. CRu included those participants who met CR Criteria 1 and 3, but with 1 or more of the following features: a) A residual LN mass &gt;1.5 cm in GTD that has regressed by more than 75% in their SPD, b) Indeterminate BM (increased number or size of aggregates).</description>
          <population>Safety analysis population. Data reported only for DLBCL and FL arm groups.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.00" upper_limit="14.82"/>
                    <measurement group_id="O2" value="0" lower_limit="0.00" upper_limit="24.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CRu</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" lower_limit="0.11" upper_limit="21.95"/>
                    <measurement group_id="O2" value="0" lower_limit="0.00" upper_limit="24.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With BOR of PR, SD, and PD at Anytime During Study in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria</title>
        <description>PR: 1) ≥50% decrease in SPD of the 6 largest dominant nodes/nodal masses. These nodes or masses selected according to the following features: a) clearly measurable in ≥2 perpendicular dimensions, b) from as disparate regions of the body as possible, and c) included mediastinal and retroperitoneal areas of disease. 2) No increase in size of other nodes (liver/spleen). 3) Splenic and hepatic nodules regressed by ≥50% in SPD. 4) With exception of splenic and hepatic nodules, involvement of other organs was considered assessable and not measurable disease. 5) BM assessment is irrelevant for determination of a PR because it was assessable and not measurable disease; however, if positive, the cell type was specified. 6) No new sites of disease. PD requires the following: 1) ≥50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders. 2) Appearance of any new lesion during or at the end of therapy. SD is defined as less than a PR but not PD.</description>
        <time_frame>From screening to up to 1 month after the last dose (received on Day 148) of study drug</time_frame>
        <population>Safety analysis population. Data reported only for DLBCL and FL arm groups.</population>
        <group_list>
          <group group_id="O1">
            <title>DLBCL: 1000 mg Obinutuzumab</title>
            <description>Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
          <group group_id="O2">
            <title>FL: 1000 mg Obinutuzumab</title>
            <description>Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With BOR of PR, SD, and PD at Anytime During Study in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria</title>
          <description>PR: 1) ≥50% decrease in SPD of the 6 largest dominant nodes/nodal masses. These nodes or masses selected according to the following features: a) clearly measurable in ≥2 perpendicular dimensions, b) from as disparate regions of the body as possible, and c) included mediastinal and retroperitoneal areas of disease. 2) No increase in size of other nodes (liver/spleen). 3) Splenic and hepatic nodules regressed by ≥50% in SPD. 4) With exception of splenic and hepatic nodules, involvement of other organs was considered assessable and not measurable disease. 5) BM assessment is irrelevant for determination of a PR because it was assessable and not measurable disease; however, if positive, the cell type was specified. 6) No new sites of disease. PD requires the following: 1) ≥50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders. 2) Appearance of any new lesion during or at the end of therapy. SD is defined as less than a PR but not PD.</description>
          <population>Safety analysis population. Data reported only for DLBCL and FL arm groups.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.7" lower_limit="7.46" upper_limit="43.70"/>
                    <measurement group_id="O2" value="61.5" lower_limit="31.58" upper_limit="86.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.1" lower_limit="10.23" upper_limit="48.41"/>
                    <measurement group_id="O2" value="30.8" lower_limit="9.09" upper_limit="61.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.1" lower_limit="19.71" upper_limit="61.46"/>
                    <measurement group_id="O2" value="7.7" lower_limit="0.19" upper_limit="36.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Complete Remission (CRe), CRe With Incomplete BM Recovery (CRi) at End of Treatment (1 Month After Cycle 8) in CLL Participants According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Guidelines</title>
        <description>CRe required the following criteria as assessed, at least 2 months from completing therapy: a) peripheral blood lymphocytes (PBL) less than (&lt;) 4 x 10^9/L, b) Absence of significant lymphadenopathy (LD) by physical examination (PE), c) No hepatomegaly/splenomegaly (HM/SM) by PE, d) Absence of constitutional symptoms and e) Blood counts above the following values (i. Neutrophils [Neu] &gt;1.5 x 10^9/L without the need for exogenous growth factors [EGF], ii. Platelets (Plt) &gt;100 x 10^9/L without the need for EGF, and iii. Hemoglobin (Hb) &gt;11.0 g/dL without blood transfusion or need for erythropoietin), and d) Once clinical and laboratory reports demonstrated CRe, a BM aspirate and biopsy was performed at least 2 months after the last treatment; to define a CRe, BM sample should be normocellular for age, &lt;30% of the cells being PBL and lymphoid nodules absent. CRi: CRe but persistent anemia/thrombocytopenia/neutropenia unrelated to CLL, but related to drug toxicity.</description>
        <time_frame>2 months after the last dose (received on Day 148) of study drug</time_frame>
        <population>Safety analysis population. Data reported only for CLL participants.</population>
        <group_list>
          <group group_id="O1">
            <title>CLL: 1000 mg Obinutuzumab</title>
            <description>Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Complete Remission (CRe), CRe With Incomplete BM Recovery (CRi) at End of Treatment (1 Month After Cycle 8) in CLL Participants According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Guidelines</title>
          <description>CRe required the following criteria as assessed, at least 2 months from completing therapy: a) peripheral blood lymphocytes (PBL) less than (&lt;) 4 x 10^9/L, b) Absence of significant lymphadenopathy (LD) by physical examination (PE), c) No hepatomegaly/splenomegaly (HM/SM) by PE, d) Absence of constitutional symptoms and e) Blood counts above the following values (i. Neutrophils [Neu] &gt;1.5 x 10^9/L without the need for exogenous growth factors [EGF], ii. Platelets (Plt) &gt;100 x 10^9/L without the need for EGF, and iii. Hemoglobin (Hb) &gt;11.0 g/dL without blood transfusion or need for erythropoietin), and d) Once clinical and laboratory reports demonstrated CRe, a BM aspirate and biopsy was performed at least 2 months after the last treatment; to define a CRe, BM sample should be normocellular for age, &lt;30% of the cells being PBL and lymphoid nodules absent. CRi: CRe but persistent anemia/thrombocytopenia/neutropenia unrelated to CLL, but related to drug toxicity.</description>
          <population>Safety analysis population. Data reported only for CLL participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CRe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.00" upper_limit="26.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CRi</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.00" upper_limit="26.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With PR, SD, and PD at End of Treatment (1 Month After Cycle 8) in CLL Participants According to IWCLL 2008 Guidelines</title>
        <description>Group A: a)Dec LN size by ≥50% either in SPD of 6 LN or largest diameter of enlarged LN (ELN) detected BT, b)Reduction (Red) in BT enlargement of liver, c)Red in BT enlargement of spleen, d)Dec in PBL by ≥50% from baseline, e)A 50% Red in BM infiltrate or B-lymphoid nodules in BM and f)No Inc in any LN and no new ELN. Group B: a)Plt count=100,000/µL or Inc of ≥50% over baseline, b)Hb &gt;11 g/dL or ≥50% Inc over baseline, c)Neu &gt; 1500/µL or &gt; 50% Inc over baseline. PR is considered as achieved if 2 of Group A criteria and 1 of Group B criteria were met for ≥2 months. PD is defined as LD (appearance of new lesion [ELN], SM, HM or other organ infiltrates) or Inc by ≥50% in greatest determined diameter of any previous site or Inc in previously noted enlargement of liver/spleen by ≥50% or new appearance of HM/SM or an Inc in number of PBL ≥50% or transformation to a more aggressive histology or occurrence of cytopenia attributable to CLL. SD is defined as less than a PR but is not PD.</description>
        <time_frame>2 months after the last dose (received on Day 148) of study drug</time_frame>
        <population>Safety analysis population. Data reported only for CLL participants</population>
        <group_list>
          <group group_id="O1">
            <title>CLL: 1000 mg Obinutuzumab</title>
            <description>Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With PR, SD, and PD at End of Treatment (1 Month After Cycle 8) in CLL Participants According to IWCLL 2008 Guidelines</title>
          <description>Group A: a)Dec LN size by ≥50% either in SPD of 6 LN or largest diameter of enlarged LN (ELN) detected BT, b)Reduction (Red) in BT enlargement of liver, c)Red in BT enlargement of spleen, d)Dec in PBL by ≥50% from baseline, e)A 50% Red in BM infiltrate or B-lymphoid nodules in BM and f)No Inc in any LN and no new ELN. Group B: a)Plt count=100,000/µL or Inc of ≥50% over baseline, b)Hb &gt;11 g/dL or ≥50% Inc over baseline, c)Neu &gt; 1500/µL or &gt; 50% Inc over baseline. PR is considered as achieved if 2 of Group A criteria and 1 of Group B criteria were met for ≥2 months. PD is defined as LD (appearance of new lesion [ELN], SM, HM or other organ infiltrates) or Inc by ≥50% in greatest determined diameter of any previous site or Inc in previously noted enlargement of liver/spleen by ≥50% or new appearance of HM/SM or an Inc in number of PBL ≥50% or transformation to a more aggressive histology or occurrence of cytopenia attributable to CLL. SD is defined as less than a PR but is not PD.</description>
          <population>Safety analysis population. Data reported only for CLL participants</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.3" lower_limit="27.67" upper_limit="84.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" lower_limit="0.21" upper_limit="38.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="2.09" upper_limit="48.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With BOR of CRe, CRi at Anytime During the Study in CLL Participants According to IWCLL 2008 Guidelines</title>
        <description>CRe required the following criteria as assessed, at least 2 months from completing therapy: a) PBL &lt;4 x 10^9/L, b) Absence of significant LD by PE, c) No HM/SM by PE, d) Absence of constitutional symptoms and e) Blood counts above the following values (i. Neu &gt;1.5 x 10^9/L without the need for EGF, ii. Plt &gt;100 x 10^9/L without the need for EGF, and iii. Hb &gt;11.0 g/dL without blood transfusion or need for EGF, and d) Once clinical and laboratory reports demonstrated CRe, a BM aspirate and biopsy was performed at least 2 months after the last treatment; to define a CRe, BM sample should be normocellular for age, &lt;30% of the cells being PBL and lymphoid nodules absent. CRi: CRe but persistent anemia/thrombocytopenia/neutropenia unrelated to CLL, but related to drug toxicity.</description>
        <time_frame>From screening to up to 2 months after the last dose (received on Day 148) of study drug</time_frame>
        <population>Safety analysis population. Data reported only for CLL participants.</population>
        <group_list>
          <group group_id="O1">
            <title>CLL: 1000 mg Obinutuzumab</title>
            <description>Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With BOR of CRe, CRi at Anytime During the Study in CLL Participants According to IWCLL 2008 Guidelines</title>
          <description>CRe required the following criteria as assessed, at least 2 months from completing therapy: a) PBL &lt;4 x 10^9/L, b) Absence of significant LD by PE, c) No HM/SM by PE, d) Absence of constitutional symptoms and e) Blood counts above the following values (i. Neu &gt;1.5 x 10^9/L without the need for EGF, ii. Plt &gt;100 x 10^9/L without the need for EGF, and iii. Hb &gt;11.0 g/dL without blood transfusion or need for EGF, and d) Once clinical and laboratory reports demonstrated CRe, a BM aspirate and biopsy was performed at least 2 months after the last treatment; to define a CRe, BM sample should be normocellular for age, &lt;30% of the cells being PBL and lymphoid nodules absent. CRi: CRe but persistent anemia/thrombocytopenia/neutropenia unrelated to CLL, but related to drug toxicity.</description>
          <population>Safety analysis population. Data reported only for CLL participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CRe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.00" upper_limit="26.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CRi</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.00" upper_limit="26.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With BOR of PR, SD, and PD at Anytime During Study in CLL Participants According to IWCLL 2008 Guidelines</title>
        <description>Group A: a)Dec LN size by ≥50% either in SPD of 6 LN or largest diameter of ELN detected BT, b)Red in BT enlargement of liver, c)Red in BT enlargement of spleen, d)Dec in PBL by ≥50% from baseline, e)A 50% Red in BM infiltrate or B-lymphoid nodules in BM and f)No Inc in any LN and no new ELN. Group B: a)Plt count=100,000/µL or Inc of ≥50% over baseline, b)Hb &gt;11 g/dL or ≥50% Inc over baseline, c)Neu &gt; 1500/µL or &gt; 50% Inc over baseline. PR is considered as achieved if 2 of Group A criteria and 1 of Group B criteria were met for ≥2 months. PD is defined as LD (appearance of new lesion [ELN], SM, HM or other organ infiltrates) or Inc by ≥50% in greatest determined diameter of any previous site or Inc in previously noted enlargement of liver/spleen by ≥50% or new appearance of HM/SM or an Inc in number of PBL ≥50% or transformation to a more aggressive histology or occurrence of cytopenia attributable to CLL. SD is defined as less than a PR but is not PD.</description>
        <time_frame>From screening to up to 2 months after the last dose (received on Day 148) of study drug</time_frame>
        <population>Safety analysis population. Data reported only for CLL participants.</population>
        <group_list>
          <group group_id="O1">
            <title>CLL: 1000 mg Obinutuzumab</title>
            <description>Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With BOR of PR, SD, and PD at Anytime During Study in CLL Participants According to IWCLL 2008 Guidelines</title>
          <description>Group A: a)Dec LN size by ≥50% either in SPD of 6 LN or largest diameter of ELN detected BT, b)Red in BT enlargement of liver, c)Red in BT enlargement of spleen, d)Dec in PBL by ≥50% from baseline, e)A 50% Red in BM infiltrate or B-lymphoid nodules in BM and f)No Inc in any LN and no new ELN. Group B: a)Plt count=100,000/µL or Inc of ≥50% over baseline, b)Hb &gt;11 g/dL or ≥50% Inc over baseline, c)Neu &gt; 1500/µL or &gt; 50% Inc over baseline. PR is considered as achieved if 2 of Group A criteria and 1 of Group B criteria were met for ≥2 months. PD is defined as LD (appearance of new lesion [ELN], SM, HM or other organ infiltrates) or Inc by ≥50% in greatest determined diameter of any previous site or Inc in previously noted enlargement of liver/spleen by ≥50% or new appearance of HM/SM or an Inc in number of PBL ≥50% or transformation to a more aggressive histology or occurrence of cytopenia attributable to CLL. SD is defined as less than a PR but is not PD.</description>
          <population>Safety analysis population. Data reported only for CLL participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0" lower_limit="42.81" upper_limit="94.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" lower_limit="0.21" upper_limit="38.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.00" upper_limit="26.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Positive Human Anti-Human Antibodies (HAHA)</title>
        <description>For the detection of HAHA, serum samples were initially analyzed using a validated enzyme linked immunosorbent assay (ELISA) method (screening assay, tier 1). The lower limit of quantification (LLOQ) in undiluted serum was 18.4 nanograms per milliliter (ng/mL). The precision ranged from 4.85 percent (%) to 16.0%. In serum samples found positive, the presence of specific anti-obinutuzumab antibodies was confirmed or excluded using the same ELISA method with an appropriate immunocompetition step (addition of excess obinutuzumab, confirmation assay, tier 2). Samples were confirmed as containing specific anti-obinutuzumab antibodies if there was a signal reduction ≥85.7% in the presence of obinutuzumab.</description>
        <time_frame>Cycle 1 (Day 1), Cycle 4 (Day 1), 4-week follow-up, 3 and 6 month follow-up</time_frame>
        <population>Safety analysis population. &quot;n&quot; represents the number of participants who were evaluable at the specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>CLL: 1000 mg Obinutuzumab</title>
            <description>Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.</description>
          </group>
          <group group_id="O2">
            <title>DLBCL: 1000 mg Obinutuzumab</title>
            <description>Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
          <group group_id="O3">
            <title>FL: 1000 mg Obinutuzumab</title>
            <description>Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Positive Human Anti-Human Antibodies (HAHA)</title>
          <description>For the detection of HAHA, serum samples were initially analyzed using a validated enzyme linked immunosorbent assay (ELISA) method (screening assay, tier 1). The lower limit of quantification (LLOQ) in undiluted serum was 18.4 nanograms per milliliter (ng/mL). The precision ranged from 4.85 percent (%) to 16.0%. In serum samples found positive, the presence of specific anti-obinutuzumab antibodies was confirmed or excluded using the same ELISA method with an appropriate immunocompetition step (addition of excess obinutuzumab, confirmation assay, tier 2). Samples were confirmed as containing specific anti-obinutuzumab antibodies if there was a signal reduction ≥85.7% in the presence of obinutuzumab.</description>
          <population>Safety analysis population. &quot;n&quot; represents the number of participants who were evaluable at the specified time point.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1, Day 1 (n=12,23,13)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 4, Day 1 (n=11,14,13)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 week follow-up (n=10,10,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 month follow-up (n=8,4,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 month follow-up (n=7,4,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Positive Human Anti-Chimeric Antibodies (HACA)</title>
        <description>Serum concentrations of HACA against rituximab were determined by ELISA. The LLOQ in undiluted serum was 5.00 relative units per milliliter (RU/mL). The precision and accuracy of the assay, as determined from the analysis of quality control samples, were satisfactory throughout the study; precision ranged from 6.4% to 13.6% and accuracy ranged from 88.2% to 94.8%.</description>
        <time_frame>Cycle 1, Day 1</time_frame>
        <population>Safety analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>CLL: 1000 mg Obinutuzumab</title>
            <description>Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.</description>
          </group>
          <group group_id="O2">
            <title>DLBCL: 1000 mg Obinutuzumab</title>
            <description>Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
          <group group_id="O3">
            <title>FL: 1000 mg Obinutuzumab</title>
            <description>Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Positive Human Anti-Chimeric Antibodies (HACA)</title>
          <description>Serum concentrations of HACA against rituximab were determined by ELISA. The LLOQ in undiluted serum was 5.00 relative units per milliliter (RU/mL). The precision and accuracy of the assay, as determined from the analysis of quality control samples, were satisfactory throughout the study; precision ranged from 6.4% to 13.6% and accuracy ranged from 88.2% to 94.8%.</description>
          <population>Safety analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With B-cell Depletion or Recovery</title>
        <description>Depletion is defined as cluster of differentiation (CD) 19+ B-cell count &lt;0.07 x10^9/L.Recovery is defined as CD19+ B-cell equal to or greater than 0.07 x 10^9/L.</description>
        <time_frame>Screening, Cycle 1 (Days 1,8), Cycle 2 (Day 1), Cycle 4 (Day 1), Cycle 6 (Day 1), Cycle 8 (Day 1), 4 weeks after last dose of study drug and every 3 months after last dose of study drug up to 1 year</time_frame>
        <population>Safety analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>CLL: 1000 mg Obinutuzumab</title>
            <description>Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.</description>
          </group>
          <group group_id="O2">
            <title>DLBCL: 1000 mg Obinutuzumab</title>
            <description>Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
          <group group_id="O3">
            <title>FL: 1000 mg Obinutuzumab</title>
            <description>Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With B-cell Depletion or Recovery</title>
          <description>Depletion is defined as cluster of differentiation (CD) 19+ B-cell count &lt;0.07 x10^9/L.Recovery is defined as CD19+ B-cell equal to or greater than 0.07 x 10^9/L.</description>
          <population>Safety analysis population.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>B-cell Depletion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B-cell Recovery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Depletion of CD19+ B-cell</title>
        <description>Depletion is defined as CD19+ B-cell count &lt; 0.07 x 10^9/L. The duration of depletion is defined as the number of days between first assessment of B-cell depletion and the first assessment where CD19+ cell count returned to at least the depletion level from baseline and not followed by any further B-cell depletion. If participant did not return to above depletion level, then the cut off is at the time of last assessment.</description>
        <time_frame>Screening, Cycle 1 (Days 1,8), Cycle 2 (Day 1), Cycle 4 (Day 1), Cycle 6 (Day 1), Cycle 8 (Day 1), 4 weeks after last dose of study drug and every 3 months after last dose of study drug up to 1 year</time_frame>
        <population>Safety analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>CLL: 1000 mg Obinutuzumab</title>
            <description>Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.</description>
          </group>
          <group group_id="O2">
            <title>DLBCL: 1000 mg Obinutuzumab</title>
            <description>Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
          <group group_id="O3">
            <title>FL: 1000 mg Obinutuzumab</title>
            <description>Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Depletion of CD19+ B-cell</title>
          <description>Depletion is defined as CD19+ B-cell count &lt; 0.07 x 10^9/L. The duration of depletion is defined as the number of days between first assessment of B-cell depletion and the first assessment where CD19+ cell count returned to at least the depletion level from baseline and not followed by any further B-cell depletion. If participant did not return to above depletion level, then the cut off is at the time of last assessment.</description>
          <population>Safety analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="238.7" spread="182.5"/>
                    <measurement group_id="O2" value="141.0" spread="167.5"/>
                    <measurement group_id="O3" value="386.0" spread="176.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Recovery of CD19+ B-cell</title>
        <description>Recovery is defined as CD19+ B-cell equal to or greater than 0.07 x 10^9/L. Time to recovery is defined as time between the beginning of depletion and first value after end of treatment that is equal or above 0.07x10^9/L and not exclusively followed by depleted values only. If participant did not return to above recovery level then set to Null.</description>
        <time_frame>Screening, Cycle 1 (Days 1,8), Cycle 2 (Day 1), Cycle 4 (Day 1), Cycle 6 (Day 1), Cycle 8 (Day 1), 4 weeks after last dose of study drug and every 3 months after last dose of study drug up to 1 year</time_frame>
        <population>Safety analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome and &quot;n&quot; represents the number of participants evaluable for the specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>CLL: 1000 mg Obinutuzumab</title>
            <description>Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.</description>
          </group>
          <group group_id="O2">
            <title>DLBCL: 1000 mg Obinutuzumab</title>
            <description>Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
          <group group_id="O3">
            <title>FL: 1000 mg Obinutuzumab</title>
            <description>Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Recovery of CD19+ B-cell</title>
          <description>Recovery is defined as CD19+ B-cell equal to or greater than 0.07 x 10^9/L. Time to recovery is defined as time between the beginning of depletion and first value after end of treatment that is equal or above 0.07x10^9/L and not exclusively followed by depleted values only. If participant did not return to above recovery level then set to Null.</description>
          <population>Safety analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome and &quot;n&quot; represents the number of participants evaluable for the specified category.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Time to recovery with PD (n=1,0,1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="419" spread="NA">Standard deviation is not applicable as data of a single participant is reported.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">No participant experienced B-cell recovery for this category.</measurement>
                    <measurement group_id="O3" value="331.0" spread="NA">Standard deviation is not applicable as data of a single participant is reported.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time to recovery without PD (n=3,1,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="229.0" spread="87.5"/>
                    <measurement group_id="O2" value="515.0" spread="NA">Standard deviation is not applicable as data of a single participant is reported.</measurement>
                    <measurement group_id="O3" value="NA" spread="NA">No participant experienced B-cell recovery for this category.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Until 3 months after last study drug (Up to approximately 9 months)</time_frame>
      <desc>Safety analysis population.</desc>
      <group_list>
        <group group_id="E1">
          <title>CLL: 1000 mg Obinutuzumab</title>
          <description>Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.</description>
        </group>
        <group group_id="E2">
          <title>DLBCL: 1000 mg Obinutuzumab</title>
          <description>Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
        </group>
        <group group_id="E3">
          <title>FL: 1000 mg Obinutuzumab</title>
          <description>Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (17.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Submandibular mass</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Infected cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (17.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Lymph node pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Scleral haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Local swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Epididymitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Scratch</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Blood pressure decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Blood uric acid increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Heart rate decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Extrapyramidal disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Communications</name_or_title>
      <organization>Hoffmann-LaRoche</organization>
      <phone>800-821-8590</phone>
      <email>genentech@druginfo.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01680991
org study id: YP25623
nct id: NCT01680991
lead sponsor: 
This multi-center, open-label, single-arm study will evaluate the pharmacokinetics and safety
      of obinutuzumab in participants with cluster of differentiation (CD) 20 positive (+)
      malignant disease. Participants will receive multiple doses of obinutuzumab. The anticipated
      time on study treatment is 24 weeks.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area Under the Serum Concentration Time Curve From Zero to Day 7 (AUC0-7) of Obinutuzumab on Day 1, Cycle 1
time frame: Cycle 1-NHL: within 2 hours (h) pre-dose (Pr-D), end of infusion (EoI), 4, 24, 72 and 120 h post-infusion (Po-I) on Day 1; CLL: within 2 h Pr-D, EoI on Days 1,2; 4, 24, 72 and 120 h Po-I on Day 2. NHL and CLL: within 2 h Pr-D on Day 8
description: DLBCL and FL are sub-types of Non-Hodgkin's Lymphoma (NHL) and time frame for these 2 groups was presented under NHL. For CLL, pharmacokinetic (PK) parameters were from Cycle 1 Day 1 and Day 2 dosing, due to split dosing.
measure: Maximum Observed Serum Concentration (Cmax) of Obinutuzumab on Day 1, Cycle 1
time frame: Cycle 1-NHL: within 2 h Pr-D, EoI, 4, 24, 72 and 120 h Po-I on Day 1; CLL: within 2 h Pr-D, EoI on Days 1,2; 4, 24, 72 and 120 h Po-I on Day 2. NHL and CLL: within 2 h Pr-D on Day 8
description: DLBCL and FL are sub-types of NHL and time frame for these 2 groups was presented under NHL. For CLL, PK parameters were from Cycle 1 Day 1 and Day 2 dosing, due to split dosing.
measure: Area Under the Serum Concentration Versus Time Curve From 0 to Day 21 (AUC0-21) of Obinutuzumab at Cycle 8
time frame: Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1
measure: Cmax of Obinutuzumab at Cycle 8
time frame: Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1
measure: Time to Maximum Observed Serum Concentration (Tmax) of Obinutuzumab at Cycle 8
time frame: Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1
measure: Apparent Terminal Half-life (t1/2)
time frame: Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1, 4-week follow-up (Day 29), 3 and 6 months after Cycle 8 dosing
description: Half-life is the time measured for the serum concentration of study drug to decrease (Dec) by one half.
measure: Volume of Distribution at Steady State (Vss) of Obinutuzumab at Cycle 8
time frame: Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1
description: Vss reflects the actual blood and tissue volume into which a drug is distributed and the relative binding of drug to protein in these spaces.
measure: Total Systemic Clearance at Steady State (CLss) of Obinutuzumab at Cycle 8
time frame: Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1
description: Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
measure: Minimum Observed Serum Concentration of Obinutuzumab
time frame: Within 2 hours Pr-D on Day 1 of Cycles 2-8 and on Days 8,15 of Cycle 1
measure: Percentage of Participants With Complete Response (CR), CR Unconfirmed (CRu) at End of Treatment (1 Month After Cycle 8) in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria
time frame: 1 month after the last dose (received on Day 148) of study drug
description: CR: 1) Disappearance of clinical and radiographic evidence of disease, related symptoms and normalization of biochemical abnormalities definitely assignable to NHL, 2) Lymph nodes (LN) and nodal masses regressed to normal size after therapy (AT) (≤1.5 centimeters [cm] in their greatest transverse diameter [GTD] for LN greater than (>) 1.5 cm before therapy [BT]). LN that were 1.1 to 1.5 cm in their GTD BT decreased to ≤1 cm in GTD AT, or >75% in the sum of the products (SPD) of the GTD, 3) Enlarged spleen regressed in size and not palpable, 4) Absence of macroscopic nodules, 5) Enlarged organs decreased in size, and 6) If the bone marrow (BM) was involved, the infiltrate must be cleared on repeat BM aspirate and biopsy. CRu included those participants who met CR Criteria 1 and 3, but with 1 or more of the following features: a) A residual LN mass >1.5 cm in GTD that has regressed by more than 75% in their SPD, and b) Indeterminate BM (increased [Inc] number or size of aggregates).
measure: Percentage of Participants With Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) at End of Treatment (1 Month After Cycle 8) in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria
time frame: 1 month after the last dose (received on Day 148) of study drug
description: PR: 1) ≥50% decrease in SPD of the 6 largest dominant nodes/nodal masses. These nodes or masses selected according to the following features: a) clearly measurable in ≥2 perpendicular dimensions, b) from as disparate regions of the body as possible, and c) included mediastinal and retroperitoneal areas of disease. 2) No increase in size of other nodes (liver/spleen). 3) Splenic and hepatic nodules regressed by ≥50% in SPD. 4) With exception of splenic and hepatic nodules, involvement of other organs was considered assessable and not measurable disease. 5) BM assessment is irrelevant for determination of a PR because it was assessable and not measurable disease; however, if positive, the cell type was specified. 6) No new sites of disease. PD requires the following: 1) ≥50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders. 2) Appearance of any new lesion during or at the end of therapy. SD is defined as less than a PR but not PD.
measure: Percentage of Participants With Best Overall Response (BOR) of CR, CRu at Anytime During Study in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria
time frame: From screening to up to 1 month after the last dose (received on Day 148) of study drug
description: CR: 1) Disappearance of clinical and radiographic evidence of disease, related symptoms and normalization of biochemical abnormalities definitely assignable to NHL, 2) LN and nodal masses regressed to normal size AT (≤1.5 cm] in their GTD for LN >1.5 cm BT). LN that were 1.1 to 1.5 cm in their GTD BT decreased to ≤1 cm in GTD AT, or >75% in the SPD of the GTD, 3) Enlarged spleen regressed in size and not palpable, 4) Absence of macroscopic nodules in any organs, 5) Enlarged organs decreased in size, and 6) If the BM was involved, the infiltrate must be cleared on repeat BM aspirate and biopsy. CRu included those participants who met CR Criteria 1 and 3, but with 1 or more of the following features: a) A residual LN mass >1.5 cm in GTD that has regressed by more than 75% in their SPD, b) Indeterminate BM (increased number or size of aggregates).
measure: Percentage of Participants With BOR of PR, SD, and PD at Anytime During Study in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria
time frame: From screening to up to 1 month after the last dose (received on Day 148) of study drug
description: PR: 1) ≥50% decrease in SPD of the 6 largest dominant nodes/nodal masses. These nodes or masses selected according to the following features: a) clearly measurable in ≥2 perpendicular dimensions, b) from as disparate regions of the body as possible, and c) included mediastinal and retroperitoneal areas of disease. 2) No increase in size of other nodes (liver/spleen). 3) Splenic and hepatic nodules regressed by ≥50% in SPD. 4) With exception of splenic and hepatic nodules, involvement of other organs was considered assessable and not measurable disease. 5) BM assessment is irrelevant for determination of a PR because it was assessable and not measurable disease; however, if positive, the cell type was specified. 6) No new sites of disease. PD requires the following: 1) ≥50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders. 2) Appearance of any new lesion during or at the end of therapy. SD is defined as less than a PR but not PD.
measure: Percentage of Participants With Complete Remission (CRe), CRe With Incomplete BM Recovery (CRi) at End of Treatment (1 Month After Cycle 8) in CLL Participants According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Guidelines
time frame: 2 months after the last dose (received on Day 148) of study drug
description: CRe required the following criteria as assessed, at least 2 months from completing therapy: a) peripheral blood lymphocytes (PBL) less than (<) 4 x 10^9/L, b) Absence of significant lymphadenopathy (LD) by physical examination (PE), c) No hepatomegaly/splenomegaly (HM/SM) by PE, d) Absence of constitutional symptoms and e) Blood counts above the following values (i. Neutrophils [Neu] >1.5 x 10^9/L without the need for exogenous growth factors [EGF], ii. Platelets (Plt) >100 x 10^9/L without the need for EGF, and iii. Hemoglobin (Hb) >11.0 g/dL without blood transfusion or need for erythropoietin), and d) Once clinical and laboratory reports demonstrated CRe, a BM aspirate and biopsy was performed at least 2 months after the last treatment; to define a CRe, BM sample should be normocellular for age, <30% of the cells being PBL and lymphoid nodules absent. CRi: CRe but persistent anemia/thrombocytopenia/neutropenia unrelated to CLL, but related to drug toxicity.
measure: Percentage of Participants With PR, SD, and PD at End of Treatment (1 Month After Cycle 8) in CLL Participants According to IWCLL 2008 Guidelines
time frame: 2 months after the last dose (received on Day 148) of study drug
description: Group A: a)Dec LN size by ≥50% either in SPD of 6 LN or largest diameter of enlarged LN (ELN) detected BT, b)Reduction (Red) in BT enlargement of liver, c)Red in BT enlargement of spleen, d)Dec in PBL by ≥50% from baseline, e)A 50% Red in BM infiltrate or B-lymphoid nodules in BM and f)No Inc in any LN and no new ELN. Group B: a)Plt count=100,000/µL or Inc of ≥50% over baseline, b)Hb >11 g/dL or ≥50% Inc over baseline, c)Neu > 1500/µL or > 50% Inc over baseline. PR is considered as achieved if 2 of Group A criteria and 1 of Group B criteria were met for ≥2 months. PD is defined as LD (appearance of new lesion [ELN], SM, HM or other organ infiltrates) or Inc by ≥50% in greatest determined diameter of any previous site or Inc in previously noted enlargement of liver/spleen by ≥50% or new appearance of HM/SM or an Inc in number of PBL ≥50% or transformation to a more aggressive histology or occurrence of cytopenia attributable to CLL. SD is defined as less than a PR but is not PD.
measure: Percentage of Participants With BOR of CRe, CRi at Anytime During the Study in CLL Participants According to IWCLL 2008 Guidelines
time frame: From screening to up to 2 months after the last dose (received on Day 148) of study drug
description: CRe required the following criteria as assessed, at least 2 months from completing therapy: a) PBL <4 x 10^9/L, b) Absence of significant LD by PE, c) No HM/SM by PE, d) Absence of constitutional symptoms and e) Blood counts above the following values (i. Neu >1.5 x 10^9/L without the need for EGF, ii. Plt >100 x 10^9/L without the need for EGF, and iii. Hb >11.0 g/dL without blood transfusion or need for EGF, and d) Once clinical and laboratory reports demonstrated CRe, a BM aspirate and biopsy was performed at least 2 months after the last treatment; to define a CRe, BM sample should be normocellular for age, <30% of the cells being PBL and lymphoid nodules absent. CRi: CRe but persistent anemia/thrombocytopenia/neutropenia unrelated to CLL, but related to drug toxicity.
measure: Percentage of Participants With BOR of PR, SD, and PD at Anytime During Study in CLL Participants According to IWCLL 2008 Guidelines
time frame: From screening to up to 2 months after the last dose (received on Day 148) of study drug
description: Group A: a)Dec LN size by ≥50% either in SPD of 6 LN or largest diameter of ELN detected BT, b)Red in BT enlargement of liver, c)Red in BT enlargement of spleen, d)Dec in PBL by ≥50% from baseline, e)A 50% Red in BM infiltrate or B-lymphoid nodules in BM and f)No Inc in any LN and no new ELN. Group B: a)Plt count=100,000/µL or Inc of ≥50% over baseline, b)Hb >11 g/dL or ≥50% Inc over baseline, c)Neu > 1500/µL or > 50% Inc over baseline. PR is considered as achieved if 2 of Group A criteria and 1 of Group B criteria were met for ≥2 months. PD is defined as LD (appearance of new lesion [ELN], SM, HM or other organ infiltrates) or Inc by ≥50% in greatest determined diameter of any previous site or Inc in previously noted enlargement of liver/spleen by ≥50% or new appearance of HM/SM or an Inc in number of PBL ≥50% or transformation to a more aggressive histology or occurrence of cytopenia attributable to CLL. SD is defined as less than a PR but is not PD.
measure: Number of Participants With Positive Human Anti-Human Antibodies (HAHA)
time frame: Cycle 1 (Day 1), Cycle 4 (Day 1), 4-week follow-up, 3 and 6 month follow-up
description: For the detection of HAHA, serum samples were initially analyzed using a validated enzyme linked immunosorbent assay (ELISA) method (screening assay, tier 1). The lower limit of quantification (LLOQ) in undiluted serum was 18.4 nanograms per milliliter (ng/mL). The precision ranged from 4.85 percent (%) to 16.0%. In serum samples found positive, the presence of specific anti-obinutuzumab antibodies was confirmed or excluded using the same ELISA method with an appropriate immunocompetition step (addition of excess obinutuzumab, confirmation assay, tier 2). Samples were confirmed as containing specific anti-obinutuzumab antibodies if there was a signal reduction ≥85.7% in the presence of obinutuzumab.
measure: Number of Participants With Positive Human Anti-Chimeric Antibodies (HACA)
time frame: Cycle 1, Day 1
description: Serum concentrations of HACA against rituximab were determined by ELISA. The LLOQ in undiluted serum was 5.00 relative units per milliliter (RU/mL). The precision and accuracy of the assay, as determined from the analysis of quality control samples, were satisfactory throughout the study; precision ranged from 6.4% to 13.6% and accuracy ranged from 88.2% to 94.8%.
measure: Number of Participants With B-cell Depletion or Recovery
time frame: Screening, Cycle 1 (Days 1,8), Cycle 2 (Day 1), Cycle 4 (Day 1), Cycle 6 (Day 1), Cycle 8 (Day 1), 4 weeks after last dose of study drug and every 3 months after last dose of study drug up to 1 year
description: Depletion is defined as cluster of differentiation (CD) 19+ B-cell count <0.07 x10^9/L.Recovery is defined as CD19+ B-cell equal to or greater than 0.07 x 10^9/L.
measure: Duration of Depletion of CD19+ B-cell
time frame: Screening, Cycle 1 (Days 1,8), Cycle 2 (Day 1), Cycle 4 (Day 1), Cycle 6 (Day 1), Cycle 8 (Day 1), 4 weeks after last dose of study drug and every 3 months after last dose of study drug up to 1 year
description: Depletion is defined as CD19+ B-cell count < 0.07 x 10^9/L. The duration of depletion is defined as the number of days between first assessment of B-cell depletion and the first assessment where CD19+ cell count returned to at least the depletion level from baseline and not followed by any further B-cell depletion. If participant did not return to above depletion level, then the cut off is at the time of last assessment.
measure: Time to Recovery of CD19+ B-cell
time frame: Screening, Cycle 1 (Days 1,8), Cycle 2 (Day 1), Cycle 4 (Day 1), Cycle 6 (Day 1), Cycle 8 (Day 1), 4 weeks after last dose of study drug and every 3 months after last dose of study drug up to 1 year
description: Recovery is defined as CD19+ B-cell equal to or greater than 0.07 x 10^9/L. Time to recovery is defined as time between the beginning of depletion and first value after end of treatment that is equal or above 0.07x10^9/L and not exclusively followed by depleted values only. If participant did not return to above recovery level then set to Null.
arm group label: CLL: 1000 mg Obinutuzumab
arm group type: Experimental
description: Participants with chronic lymphocytic leukemia (CLL) will receive 1000 milligrams (mg) obinutuzumab as an intravenous (IV) infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. The first infusion on Cycle 1 Day 1 will be given over two days: Day 1 and Day 2. Additional doses of obinutuzumab will be administered on Cycle 1 Day 8 and Day 15.
arm group label: DLBCL: 1000 mg Obinutuzumab
arm group type: Experimental
description: Participants with diffuse large B-cell lymphoma (DLBCL) will receive 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab will be administered on Cycle 1 Day 8 and Day 15.
arm group label: FL: 1000 mg Obinutuzumab
arm group type: Experimental
description: Participants with follicular lymphoma (FL) will receive 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab will be administered on Cycle 1 Day 8 and Day 15.
intervention type: Drug
intervention name: Obinutuzumab
description: Multiple doses of obinutuzumab.
arm group label: CLL: 1000 mg Obinutuzumab
arm group label: DLBCL: 1000 mg Obinutuzumab
arm group label: FL: 1000 mg Obinutuzumab
other name: RO5072759
other name: GA101
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Lymphoma, Follicular
mesh term: Lymphoma, Large B-Cell, Diffuse
mesh term: Leukemia, Lymphocytic, Chronic, B-Cell
mesh term: Obinutuzumab
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 